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GASTROENTEROLOGY 2012;143:e18–e41

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Multisociety Sedation Curriculum for Gastrointestinal Endoscopy

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Podcast interview: www.gastro.org/gastropodcast.Also available on iTunes.

Table of Contents

Introduction—VargoSedation Pharmacology—DeLeggeInformed Consent for Endoscopic Sedation—FeldPeriprocedure Assessment for Endoscopic Procedures—

KwoLevels of Sedation—LightdaleTraining in the Administration of Specific Agents for

Moderate Sedation—GerstenbergerTraining in Airway/Rescue Techniques and Management

of Complications—RexAnesthesiologist Assistance for Endoscopic Procedures—

VargoIntraprocedure Monitoring—NuccioPostprocedure Assessment Training—VargoEndoscopy in Pregnant and Lactating Women—VargoAssessment of Competency in Endoscopic Sedation—

SchillerBibliographyAppendix: Primer in Sedation Pharmacology—DeLegge

The Multisociety Sedation Curriculum for Gastroin-testinal Endoscopy (MSCGE) grew out of the need

or a complete and programmatic approach to the trainingf procedure sedation. As a natural outgrowth of the Gas-roenterology Core Curriculum, the sponsoring societieshought that a comprehensive document covering the as-ects of procedure sedation from pharmacology, periproce-ure assessment, airway management, and the use of anes-hesia services was necessary for a variety of reasons. Chiefmong these was to ensure a standardized basis for instruc-ion through the use of competency-based training.

This constitutes a living document that represents theponsoring societies’ vision of best practices in procedureedation training based on published data and expert con-ensus. It provides a framework for developing an individuallan of study and growth that should be tailored to meet theeeds of each individual trainee based on the strengths andpecial qualities of each individual training program. Addi-ionally, the curriculum can serve the practicing gastroenter-logist in the updating of both knowledge and skills. Theurriculum will continue to evolve with time as new knowl-dge, methods of learning, novel techniques and technolo-ies, and challenges arise. This edition has been divided into

n overview of training and 11 sections encompassing the

readth of knowledge and skills required for the practice ofrocedural sedation for GI endoscopy.

This MSCGE represents a joint collaborative effort amonghe national gastroenterology societies—the American Asso-iation for the Study of Liver Diseases, the American Collegef Gastroenterology, the American Gastroenterological As-ociation Institute, and the American Society for Gastroin-estinal Endoscopy. In addition, the Society for Gastroenter-logy Nurses and Associates played a crucial role in theevelopment of the MSCGE. Other professional non-GIocieties and regulatory organizations were invited to takeart in the development of the MSCGE. This included themerican Association of Nurse Anesthetists, the Americanociety of Anesthesiologists (ASA), and the Centers for Medi-are and Medicaid Services (CMS). The American Associa-ion of Nurse Anesthetists did not respond to inquiries, CMSecided not to participate, and the ASA appointed a nonvotingbserver who participated in the developmental process.

The executive committees of each of the sponsoringocieties, as well as several subject matter experts, madepecific recommendations for revising the core curricu-um. Each society then named representatives who wereharged with overall responsibility for developing, com-unicating, and distributing the curriculum. Through-

ut this document, the paramount importance of practicend research based on the highest principles of ethics,umanism, and professionalism is reinforced.

Sedation PharmacologyImportanceEndoscopic sedation strives to seek a balance be-

tween patient comfort and drug-related side effects. Op-timal sedation allows the patient the greatest degree ofcomfort while preserving the greatest degree of safety. Toachieve this, the endoscopist must fully understand thesedation that he or she is are using. This also requirescareful consideration of the patient, the endoscopy facil-

This article is being published jointly in 2012 in Gastroenterology,American Journal of Gastroenterology, Gastrointestinal Endoscopy,Hepatology, and on the Society of Gastroenterology Nurses andAssociates’ website.

Abbreviations: ACLS, Advanced Cardiac Life Support; ASA, AmericanSociety of Anesthesiologists; BIS, bispectral index; CMS, Centers forMedicare and Medicaid Services; MSCGE, Multisociety Sedation Curric-ulum for Gastrointestinal Endoscopy.

© 2012 by the AGA Institute, American College of Gastroenterology,American Society for Gastrointestinal Endoscopy, American Society for the

Study of Liver Disease, and Society of Gastroenterology Nurses andAssociates.

0016-5085/$36.00

doi:10.1053/j.gastro.2012.05.001

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July 2012 AGA e19

ity, and the variables of the procedure itself. Patient fac-tors include age, weight, medical history, concurrent med-ications, intubation assessment, preprocedure anxiety,and pain tolerance. Procedure variables include theamount of anticipated discomfort, the duration of exam-ination, and how invasive the procedure will be. The drugsmost widely used for endoscopic sedation were the ben-zodiazepines and opioids. Recently, there has been grow-ing interest in the use of other agents with unique phar-macologic properties designed to enhance sedation andanalgesia. The endoscopist should be familiar with thesedation agents used including the drug’s pharmacoki-netic parameters (time of onset, peak response, and dura-tion of effect), pharmacodynamic profile (individual vari-ations in clinical response to a drug), elimination profile,potential adverse effects, and drug-drug interactions.

Goals of TrainingTrainees should gain an understanding of the follow-

ing:1. The pharmacokinetics and pharmacodynamics of dif-

ferent sedation agents, their synergy and potential in-teractions with other medications and potential ad-verse reactions.

2. Mastery of the titration of these agents for the desiredlevel of sedation. For the vast majority of endoscopiccases, this should be moderate sedation.

Training Process

1. Trainees should develop a thorough knowledge of thepharmacokinetics and pharmacodynamics of sedationagents before embarking on endoscopic training.

2. Trainees should develop expertise in the administra-tion of sedation medications under direct supervisionin the endoscopy suite. If a high-fidelity sedation sim-ulator is available, this should be used before trainingin the endoscopy suite. A brief primer in sedationpharmacology is provided in Appendix A.

Assessment of CompetenceKnowledge of sedation pharmacology should be

assessed as part of the overall evaluation of trainees ingastroenterology during the fellowship. Questions relat-ing to sedation pharmacology should be included on theboard examination and should reflect a general knowl-edge of this content.

Informed Consent for EndoscopicSedationImportanceThe ethical and legal requirement to obtain informed

consent before performing endoscopy derives from the con-cept of personal (patient) autonomy. The competent patient,after receiving appropriate disclosure of the material risks ofthe procedure and understanding those risks and the bene-fits and alternative approaches, makes a voluntary and un-

coerced informed decision to proceed.

The process of obtaining informed consent is both a basicethical obligation and also a legal requirement for physi-cians. It allows the patient to gain an understanding of theproposed treatment and the risks involved, as well as learnabout alternatives or voice any concerns or questions. Thephysician has the opportunity to ask about the patient’streatment goals and discover any patient-specific informa-tion that will enable the most optimal choice of treatment.When an informed patient agrees to proceed with a course oftreatment, this allows substantial transfer of the risk ofadverse outcome to the patient who understands and ac-cepts the imperfect nature of the procedure and therapy.

Most state laws specify that obtaining informed con-sent is a nondelegatable duty, ie, it must be performed bythe physician and cannot be relegated to one’s staff orendoscopy nurse. However, consent is a process, and ifsufficient and thorough information is provided, the finalportion, in which the physician finalizes consent beforethe procedure and asks the patient whether there are anyother questions remaining, may be very brief. This is mostimportant for the success of an open-access process, sothat open-access patients have already received informa-tion and have been given the opportunity to ask questionsto satisfaction before preparation for the procedure. Lan-guage issues need to be addressed by using an interpreter.If the patient is unable to give consent, an appropriatelegal representative should be sought.

A risk management recommendation particularly rele-vant for informed consent for open access is to have anintake/preparation process for open access in which thepatient is sent or verbally given information about theprocedure, including the purpose, description of the pro-cedure, and risks, benefits, and alternatives. It would beuseful to instruct the patient to call in if any concerns orquestions occur after having read the information anddocument this instruction. Further, one could instructthe office staff to be alert to patients who appear uncer-tain, seem to have many questions, or very worried aboutproceeding; these patients may be best served with apreprocedure consultation. At the time of the open access,the physician can meet state law obligation by brieflysummarizing the information.

The nature of moderate sedation is such that a patientmay perceive, but may not be aware of the context andsurroundings to sufficiently understand the implicationsof a demand to stop the procedure. The discomfort islikely to be short-lived and the procedure safe and suc-cessful, and often the patient has no recall of difficulty orany request to stop the procedure. Additional medicationor additional techniques may allow more comfortablecompletion of the procedure. Indeed, the patient maywish the discomfort to stop, not the procedure! However,the endoscopist and staff must be aware that consent canbe withdrawn. The author surmises, based on conversa-tions with experienced endoscopists, that most requeststo stop are not truly withdrawal of consent, but an artifactof sedation causing misperception of the context of pro-

cedure activity. However, the prudent endoscopist will

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carefully evaluate a request to stop, assessing, for example,whether the patient is speaking in full coherent sentencesor mumbling incomprehensibly, to be as certain as pos-sible that it is not a true withdrawal of consent.

Goals of TrainingDuring training, the trainee should gain an under-

standing of the following:

I. The principles of informed consentA. Capacity to give consentB. Material risks of endoscopic sedationC. Shared decision making

1. Discussion of sedation alternatives, from nosedation to anesthesiologist-provided generaldeep sedation.

D. Exemptions for the consent requirement1. Emergency exception/waiver

E. Withdrawal of consentF. Regulatory and institutional requirements to ob-

tain and document consentII. Understand that informed consent includes endo-

scopic sedation as well as endoscopic procedures, ie, itapplies to the sedation portion of the global proce-dure experience

III. Understand the special situations and considerations,such as the applications of informed consent in anopen-access setting

IV. Understand shared decision-making conceptsV. Understand the concept of withdrawal of consent

A. An ineffectively sedated patient has the right todemand that the procedure be stopped, eventhough partially sedated.

B. Be aware of risk factors for ineffective sedation,which may prompt withdrawal of consent in apatient expecting significant sedation. These in-clude chronic narcotic and/or anxiolytic use withpatients in whom anxiolytic/narcotic sedation isplanned and medical conditions that may pre-clude effective sedation, such as chronic obstruc-tive pulmonary disease, cor pulmonale, advancedcardiomyopathy, and severe obstructive sleep ap-nea.

VI. Give the patient the opportunity to ask questions.

Training ProcessA short training process will likely be sufficient

because most trainees will already have a basic under-standing of informed consent. Targeted review and train-ing for endoscopic sedation may include reading materi-als and/or lecture(s) and/or direct observation of facultywith discussion by faculty.

Assessment of CompetenceAdequacy of learning may be assessed by written

examination and/or oral discussion with faculty and/or

observation by faculty.

Periprocedure Assessment forEndoscopic ProceduresImportancePeriprocedure assessment is a crucial component

of the practice of endoscopic sedation. Preprocedure as-sessment should encompass a thorough review of thepatient’s sedation history, the identification of medicalconditions that may increase the risk of procedure seda-tion, and balance these findings with the type of proce-dure scheduled and the targeted level of sedation. Intrap-rocedure assessment encompasses the maintenance ofstable and safe cardiovascular parameters and level ofsedation. The postprocedure assessment focuses on ensur-ing the recovery of baseline physiologic parameters andthe identification of any complications. The traineesshould be competent in the periprocedure assessment ofthe patients undergoing sedation for all GI endoscopicprocedures.

Goals of TrainingDuring fellowship, trainees should obtain a com-

prehensive understanding of the following during thepreprocedure evaluation of patients undergoing endo-scopic procedures with sedation:

1. Confirm the patient’s suitability to undergo the plannedprocedure at the targeted sedation level (Table 1).

2. The trainee will obtain a directed history that addressesthe potential influence on the procedure and the an-ticipated level of sedation with particular attention tothe following:a. Cardiopulmonary disease (ischemic heart disease,

congestive heart failure, asthma, chronic obstructivepulmonary disease). Assessment for obstructivesleep apnea, stridor, neurologic, or seizure disorders.Previous experience with procedural sedation shouldalso be queried.

b. A complete list of medications, including over-the-counter agents, and allergies should be recorded.

c. The patient should be assessed according to the ASAphysical status classification scale (Table 1).

3. Trainees will gain knowledge about the role of moder-ate sedation in ASA classes 1 through 3.

4. Trainees must ascertain the duration of fasting beforea procedure, ie, 2 hours after clear liquid intake and 6hours after a light meal before sedation to allow ad-ministration of moderate sedation or anesthesiologist-directed sedation. These intervals should be length-ened in the setting of gastric-emptying abnormalities.

5. The trainee will perform a targeted physical examina-tion, including vital signs with heart rate, blood pres-sure, and baseline oxygen saturation. The patientshould have a cardiopulmonary assessment to screenfor stridor, wheezing, heart murmurs or arrhythmias,as well as an abdominal examination for surgical scarsand masses. A limited neurologic examination should

assess presedation mental status orientation to assess

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for obvious focal deficits. Finally, a detailed evaluationof the airway, including body habitus, neck structure,cervical spine, hyoid mental distance, and oropharynx,should be performed.

. Trainees should gain knowledge about periprocedureendoscopic sedation in special circumstances, such aspregnancy. Trainees should clearly document the pa-tient’s preanesthesia assessment history, physical ex-amination, and informed consent. Before administra-tion of anesthesia, a time out should be performedaccording to the Joint Commission’s Universal Proto-col and should include, at a minimum, the procedureteam’s agreement as to the patient’s identity and thetype of procedure to be performed.

Assessment of CompetencyProcedure assessment for endoscopic procedures

should be assessed as part of the overall evaluation oftrainees in gastroenterology during fellowship. Questionsrelating to procedure assessment should be included onthe board examination and should reflect a generalknowledge of this content.

Levels of SedationImportanceIn recent years, the Joint Commission has identi-

fied the following 4 levels of sedation, which stretch alonga continuum without clear boundaries: minimal sedationor anxiolysis, moderate sedation, deep sedation, and gen-eral anesthesia. To date, these levels of sedation have beendefined by a patient’s response to verbal, light tactile, orpainful stimuli, although they are generally also associ-ated with physiologic changes in patient vital signs.Viewed from the perspective of a continuum of sedation,targeting minimal levels of sedation by definition createsthe potential for patients to become deeply sedated. Ac-

Table 1. ASA Physical Status Classification

PS 1 Normal healthy patient Noa

PS 2 Patients with mild systemic disease Nocs

PS 3 Patients with severe systemic disease Som1aos

S 4 Patients with severe systemic disease that isa constant threat to life

Hasps

S 5 Moribund patients who are not expected tosurvive without the operation

Notmh

S 6 A declared brain-dead patient who organs arebeing removed for donor purposes

SA, American Society of Anesthesiologists; PS, physical status;ailure.

cordingly, it has been recommended that all providers be

prepared to rescue patients from deeper levels of sedationthan targeted. It should be noted that there are no phys-iologic data to support these definitions.

Most cardiopulmonary events during GI endoscopystem from hypoventilation cascading into hypoxia andcardiac decompensation. As a basic component of moni-toring, pulse oximetry has become a standard of care inendoscopy units around the world. Yet, pulse oximetrymay not adequately reflect hypoventilation, apnea, im-pending hemodynamic instability, or vasoconstrictiveshock. In particular, patients may be well saturated withoxygen and still experience significant carbon dioxide re-tention. Technological advances in the past decade haveenabled the practical measurement of real-time end-tidalcarbon dioxide and ventilatory waveforms in nonintu-bated patients. In this way, capnography has emerged as anoninvasive way of measuring patient ventilation thatmay be especially useful in patients undergoing deeperlevels of sedation.

Consensus also dictates that levels of sedation are di-rectly related to patient risks. Minimal sedation impliesthe retention of a patient’s ability to respond voluntarilyto vocal commands (eg, “take a deep breath” or “turn onyour back”) and to maintain a patent airway with protec-tive reflexes. Moderate sedation describes a depth of seda-tion at which patients are able to tolerate unpleasantprocedures while maintaining adequate cardiorespiratoryfunction, protective airway reflexes, and the ability to reactto verbal or tactile stimulation. Deep sedation implies amedically controlled state of depressed consciousnessfrom which the patient is not easily aroused, but canrespond purposefully to painful stimulation. General an-esthesia describes the deepest level of sedation whereinthe patient is unarousable with painful stimuli. Generallyspeaking, depth of sedation is directly related to cardio-vascular and airway instability; the deeper the level of

nic, physiologic, or psychiatric disturbance; excludes the very youngvery old; healthy with good exercise tolerancectional limitations; has a well-controlled disease of 1 body system;olled hypertension or diabetes without systemic effects, cigaretteing without COPD; mild obesity, pregnancyunctional limitation; has a controlled disease of �1 body system orjor system; no immediate danger of death; controlled CHF, stablea, previous heart attack, poorly controlled hypertension, morbidity, chronic renal failure; bronchospastic disease with intermittenttomsleast 1 severe disease that is poorly controlled or at end stage;ible risk of death; unstable angina, symptomatic COPD,tomatic CHF, hepatorenal failureected to survive �24 h without surgery; imminent risk of death;

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sedation, the more a patient is considered to be at risk of

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cardiopulmonary events (Table 2). Monitored anesthesiacare may include varying levels of sedation, analgesia, andanxiolysis as necessary.

Goals of TrainingTrainees in endoscopic sedation should gain an

understanding of the following:

1. The concept of sedation depth as a continuum2. Definitions (stimulus and effect) of the 4 codified levels

of sedation and expected physiologic changes in vitalsigns for each

3. Clinical training in targeting appropriate levels of se-dation for patients and/or procedures

4. Patient and/or procedure factors that may affect thedepth of sedation targeted and/or achieved

5. Clinical training in assessing levels of sedation contin-uously throughout a procedure

6. The difference between oxygenation and ventilation, aswell how these physiologic processes are reflected byvarious patient monitors

7. Indications for advanced clinical monitoring duringendoscopic procedures, including capnography

Training ProcessTraining should take place within the framework

of clinical care and problem solving. Successful programsrequire skilled and experienced endoscopic instructorswho continually maintain and improve the instructionaltalents required to teach endoscopy and the periprocedureassessment that is crucial to the performance of suchprocedures. A structured training experience coupled withongoing evaluation of trainees’ progress should be used.

Assessment of CompetenceKnowledge of periprocedure assessment should be

assessed as part of the overall evaluation of trainees ingastroenterology during the Fellowship program. Ques-tions relating to periprocedure assessment should be in-cluded in the board examination and should reflect a

Table 2. Ramsay Sedation Scale

Response to verbal stimulation Numerical score

Agitated 6Responds readily to name spoken in normal

tone5

Lethargic response to name spoken innormal tone

4

Responds only after name called loudly and/or repeatedly

3

Responds only after mild prodding orshaking

2

Does not respond after mild prodding orshaking

1

Does not respond to test stimulus 0

general knowledge of this content.

Training in the Administration ofSpecific Agents for Moderate SedationImportanceThe safe and effective administration of pharma-

cologic agents to induce and maintain a state of moderatesedation is a core skill essential to the performance of GIendoscopic procedures. All trainees should receive com-prehensive instruction in the selection and administrationof agents used for moderate sedation. Although moderatesedation for endoscopic procedures is most often achievedthrough the intravenous bolus delivery of opioids andbenzodiazepines, trainees should understand that moder-ate sedation may also be induced and maintained withcombination regimens using propofol. Although propofolused in combination with other agents is a valuable op-tion for moderate sedation, deep sedation generally re-sults when it is administered as a single agent for endo-scopic sedation. Trainees should recognize that deepsedation may also result from conventional sedation tech-niques using only opioids and benzodiazepines even whenmoderate sedation is targeted.

As the use of propofol has rapidly expanded across thespectrum of endoscopic sedation and anesthesia, the spe-cific manner in which it is used, including bolus or con-tinuous-infusion dosing schemes, whether it is used incombination with adjunctive sedating and analgesicagents, and the type of health care provider (registerednurse, nurse anesthetist, physician endoscopist, anesthe-siologist, nonanesthesiologist physician) who administersor supervises its use has varied widely in the United Statesand around the world. This variation is attributable todiffering institutional history and professional culture,legal and regulatory requirements, issues of training andcredentialing, and economic factors. Endoscopists who donot personally administer propofol or direct its use muststill be prepared to make decisions when propofol-medi-ated sedation by an anesthesia provider is appropriate.They must be skilled in the recognition of delayed propo-fol-related adverse events that may arise after recoveryfrom sedation, such as fever, chills, or myalgia that mayarise within 48 hours of administration. In many states, acertified registered nurse anesthetist must be supervisedby the physician endoscopist if the certified registerednurse anesthetist is not otherwise supervised by an anes-thesiologist. Endoscopists may also assume responsibilityat a managerial or ownership level for the development,approval, and monitoring of policies and procedures de-fining how propofol is procured, stored, administered,and accounted for in their units. The technique of titrat-ing propofol to a level of moderate sedation after lowpresedation doses of an opioid, benzodiazepine, or both isknown as balanced propofol sedation, which is a formof nonanesthesiologist-administered propofol sedation.Moderate sedation using propofol may also be achievedusing a computer-assisted personalized sedation system

known as SEDASYS, which at this time is experimental

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though has been granted “approvable” status by the U.S.Food and Drug Administration.

Although moderate sedation, during which the patientresponds purposefully to verbal commands, either aloneor accompanied by light tactile stimulation, is an appro-priate target level of sedation for most endoscopic proce-dures, deep sedation, during which the patient is noteasily arousable but is purposely responsive after repeatedor painful stimulation, should be anticipated when pa-tient-related or procedure-related factors suggest thatmoderate sedation may be inadequate. The trainee must befamiliar with these factors and must recognize that transientdeep sedation at some time during endoscopic procedures isa frequent outcome of conventional sedation using benzo-diazepines and opioids, even when these agents are specifi-cally titrated with the intent of maintaining moderate seda-tion.

Although unintended periods of deep sedation mayoccur when moderate sedation is targeted, the plannedtargeting of deep sedation raises specific regulatory con-cerns in addition to requiring a higher level of compe-tency in rescue techniques. The CMS has defined moder-ate sedation, as described previously, to be outside thescope of anesthesia services and thus exempt from thefacility requirements to which hospitals are subject whenanesthesia is provided. In contrast, targeted deep sedationor general anesthesia requires elements of the preanesthe-sia and postanesthesia evaluations that must be docu-mented in the medical record and require that theseevaluations and the anesthesia care itself be provided onlyby individuals who are qualified under statute §482.52(a)to administer anesthesia. Deep sedation, in contrast tomoderate sedation, is currently viewed by the CMS to bea form of anesthesia (monitored anesthesia care), andthus deep sedation is subject to the statutory require-ments that are applicable to anesthesia services in general.

The selection and dosing of sedation agents must reflectan understanding of key principles of endoscopic sedation.

1. An individual patient’s response to each sedation agentis unique. Response may be related to age, weight, andpharmacologic profile as well as unpredictable andunidentified factors. This patient-specific unique re-sponse necessitates careful titration to effect and to theprocedure needs rather than strict adherence to stan-dard dosing regimens.

2. Accumulation of drug effect occurs with repeated dos-ing, necessitating an understanding and considerationof time to onset of action, time to peak action, and thehalf-life of action for each agent used.

3. Synergism of drug effect occurs among sedatingagents, necessitating appropriate dose reductions.

4. Levels of stimulation during the course of endoscopicprocedures may vary markedly, potentially necessitat-ing related adjustments to the depth of sedation dur-ing the procedure. Anticipation of periods of increased

noxious stimulation allows anticipatory strategic dos-

ing schemes, particularly if propofol is used in thebalanced moderate sedation model.

Goals of TrainingDuring a fellowship, trainees should gain an un-

derstanding of the following:

1. Appropriate selection of patients for moderate seda-tion based on findings from personal consultation andconsideration ofa. The nature of the intended procedureb. Comorbiditiesc. Airway factors and other physical factors potentially

affecting the sedation processd. Pharmacologic profilee. History of illicit drug or alcohol usef. Psychiatric profileg. Sedation/anesthesia history (including intolerance

or potential allergy to any of the planned drugs)h. Patient expectations and consent issues relating

specifically to the sedation process. Pharmacologic profiles of drugs used for endoscopic

sedation (see Sedation pharmacology section andTable 3)

. Dosing regimens for induction and maintenance ofmoderate sedation that reflect consideration of age,weight, and pharmacologic synergy that include appro-priate time intervals between doses and maximum rec-ommended doses for commonly used moderate seda-tion agents and antagonistsa. Meperidineb. Fentanylc. Naloxoned. Diazepame. Midazolamf. Flumazenilg. Propofolh. Ketaminei. Nitrous oxidej. Dexmedetomidine

k. Diphenhydraminel. Promethazine

m. Droperidoln. Fospropofol

. Regulatory issues (including issues related to U.S. Foodand Drug Administration labeling; CMS definitions ofsedation and anesthesia; pertinent state laws; institu-tional regulations, policies, and procedures; and issuesrelated to diversion control)

. Safe injection practices

. Documentation of drug administration

. Supervision/direction of delivering sedation agents andmonitoring the patient’s status. This should include ef-fective and constant communication among members ofthe endoscopy sedation team, including the manner inwhich drug orders are provided to nursing staff andinformation regarding the patient’s status is shared with

the responsible physician endoscopist.

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8. Dynamic decision making related to depth of sedationand procedure tolerance (see Anesthesiologist Assis-tance for Endoscopic Procedures section)

9. Determining failure of moderate sedation and institu-tion of alternative management strategies (see Anesthe-siologist Assistance for Endoscopic Procedures)

Training ProcessTraining in the administration of sedation agents

should take place within the framework of general train-ing in endoscopy, although it should be structured andevaluated as a distinct component of endoscopic compe-tency.

Cognitive training. Didactic training should in-orporate lectures and independent study of a core ofssential literature.

Procedure training. Level 1: Use of a high-fidelityedation simulator, if available. Observation of facultyhysician managing sedationLevel 2: Independent ordering of sedation drug admin-

stration under faculty supervision

Case ReviewTrainees should participate in the discussion of

Table 3. Pharmacologic Profile of Drugs Used for Endoscopic

DrugOnset of

action, minPeak

effect, minDuratieffect

exemedetomidine, �g �5 15 UnknDiazepam, mg 2-3 3-5 3

Diphenhydramine, mg 2-3 60-90 �2

Droperidol, mg 3-10 30 120-

Fentanyl, �g 1-2 3-5 30-

lumazenil, mg 1-2 3

Ketamine, mg �1 1 10-

Meperidine, mg 3-6 5-7 60-1

Midazolam, mg 1-2 3-3 15-

Naloxone, mg 1-2 5 30-Nitrous oxide 2-3 Dose dependent 15-

Promethazine, mg 2-5 Unknown �1

Propofol, mg �1 1-2 4-

MAOI, Monoamine oxidase inhibitor.*For healthy individual �60 years of age.

cases of sedation-related adverse events.

Assessment of Competence

1. Written test2. Subjective assessment of faculty supervisor specific to

sedation-related competency pertaining to use of seda-tion agents

3. Sedation outcomes assessment, including cardiopul-monary events and related interventions, unplannedprocedure termination, and unplanned hospital admis-sion or anesthesiology or critical care management

4. Knowledge of the use of sedation agents targeted tomoderate sedation should be assessed as part of theoverall evaluation of trainees in a gastroenterologyfellowship program. This will require knowledge of thepharmacology of the sedation agents and mastery ofthe continuum of sedation with the ability to providerescue when deeper than intended levels of sedation arereached. See (Table 3, Appendix A).

Training in Airway/Rescue Techniquesand Management of ComplicationsImportanceSedation accounts for a substantial proportion of

endoscopic complications. The most common serious andlife-threatening complications related to sedation are re-

dation*

ofin Initial dose

Pharmacologicantagonist Side effects

1/kg None Hypotension, bradycardia5-10 Flumazenil Respiratory depression,

chemical phlebitis25-50 None Dizziness, prolonged

sedation1.25-2.5 None QT interval prolongation,

ventricular arrhythmia,extrapyramidal effects

50-100 Naloxone Respiratory depression,vomiting

0.1-0.3 Agitation, withdrawalsymptoms

0.5/kg None Emergence reaction,apnea, laryngospasm

25-50 Naloxone Respiratory depression,pruritus, vomiting,interaction with MAOI

1-2 Flumazenil Respiratory depression,disinhibition

0.2-0.4 Narcotic withdrawalTitrate to effect None Respiratory depression,

headache12.5-25 None Respiratory depression,

hypotension,extrapyramidal effects

10-40 None Respiratory depression,cardiovascularinstability

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60

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15

80

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spiratory in etiology. Of these, the most serious is aspira-

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tion because its consequences may be impossible to cor-rect or prevent once substantial aspiration has occurred.Even minor episodes of aspiration may result in pro-longed coughing, bronchospasm, or pulmonary infec-tions. Thus, avoidance of pulmonary aspiration is criticalfor safe endoscopic practice.

The most common respiratory events during endos-copy are related to hypoventilation induced by sedationagents. These events are related to the depth of sedationand may result from suppression of respiratory drive inthe central nervous system or from airway collapse thatoccurs with sedation. Although avoidance of these eventscan be largely achieved by preprocedure airway assessmentfollowed by titration of sedation doses to the minimaldepth of sedation needed to complete the procedure andensure adequate patient satisfaction, the variable pharma-cologic response to all available sedatives means that theoccurrence of impaired respiration is arguably more of anexpected part of an endoscopic sedation than a compli-cation. The term complication is probably better appliedto any consequences of hypoventilation that are notpromptly corrected by the managing team and lead tosustained adverse consequences including death, neuro-logic or other permanent sequelae, and pulmonary infec-tion. As such, the ability to recognize an increased risk ofapnea and airway obstruction and to apply correctivemeasures promptly and effectively is fundamental to theperformance of endoscopy.

Cardiovascular complications are less commonly lifethreatening during endoscopy, and, when life threatening,they most often follow a period of inadequate ventilationand hypoxemia. Nevertheless, the physiologic response tosedation and the physical stress of endoscopy is quitevariable. Individual patients have a susceptibility to va-gally mediated bradycardia and hypotension that can beprecipitated by simple placement of an intravenous cath-eter or stretching the sigmoid mesentery during passageof a colonoscope. In other patients, marked tachycardiamay develop if the procedure is started when they areinadequately sedated, particularly during upper endo-scopic procedures. Hypertension is seen commonly dur-ing endoscopic procedures and is often aggravated bypatients not taking their medications for hypertension onthe day of the procedure. Although hypotension andhypertension during endoscopy very rarely result in per-manent complications, they occasionally reach levels forwhich corrective action is appropriate. Finally, atrial orventricular arrhythmias are rarely precipitated by sedationor stress of the procedure. The endoscopist must be ableto accurately diagnose arrhythmia, recognize when ar-rhythmias are life threatening or resulting in cardiovas-cular compromise, and institute corrective measures whenappropriate.

Goals of TrainingDuring training, trainees should gain an under-

standing of the following:

1. Anatomy of the mouth, pharynx, hypopharynx, andnasopharynx. This should include use of the modifiedMallampati classification, which may predict the easeof endotracheal intubation (Fig. 1).

2. Conditions associated with an increased risk of pul-monary aspiration including active upper GI hemor-rhage, achalasia, bowel obstruction with gastric dis-tention, and delayed gastric emptying

3. Patient positioning to reduce the risk of aspirationsuch as elevation of the head of the bed

4. Signs that gastroesophageal reflux or emesis is or maybe occurring during endoscopy and necessitate pro-tective measures including frank emesis, droolingduring colonoscopy, excessive retained fluid in theesophagus or stomach, hiccoughing, and protractedcoughing

5. Clinical signs of apnea including the absence of chestwall and diaphragmatic movement (abdominal wallmovement), absence of air movement at the mouth,and interpretation of capnography readings

6. Clinical signs of airway obstruction including snor-ing, laryngospasm, paradoxical chest movement, ab-sence of air movement at the mouth, and interpreta-tion of capnography readings

7. The relationship of hypoxemia to impaired ventila-tion in patients using and not using supplementaloxygen

8. The use of supplemental oxygen to treat and prevent

Figure 1. Modified Mallampati Classification. Class 1, full visibility oftonsils, uvula, and soft palate; class 2, visibility of hard and soft palate,upper portion of tonsils, and uvula; class 3, soft and hard palate andbase of the uvula are visible; class 4, only hard palate is visible.

hypoxemia

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9. Indications for and performance of the head-tilt ma-neuver

10. Indications for and performance of the chin-lift orjaw-thrust maneuver

11. Indications for and placement of a nasopharyngealairway

12. Indications for and placement of an oropharyngealairway

13. Indications for and performance of bag-mask venti-lation

14. Indications for, contraindications to, and placementof a laryngeal mask airway

15. Indications for, contraindications to, and dosing ofnaloxone

16. Indications for, contraindications to, and dosing offlumazenil

17. Completion of Advanced Cardiac Life Support(ACLS) certification, including recognition of com-mon atrial and ventricular arrhythmias, interpreta-tion of the significance of arrhythmias, managementof arrhythmias, and performance of cardiopulmonaryresuscitation

18. Indications for and dosing and administration ofatropine or glycopyrrolate or vagolytic agents fortreatment of bradycardia

19. Indications for and use of position change and fluidbolus for the management of hypotension

20. Indications for, contraindications to, and dosing ofintravenous agents for the treatment of severe hypo-tension, including ephedrine

21. Indications for, contraindications to, and dosing ofintravenous agents for the treatment of severe hyper-tension, including �-blockers

Training ProcessTrainees should complete the ACLS training or the

equivalent, such as the Advanced Trauma Life Supportcourse that includes hands-on airway training, and hold avalid ACLS certificate. Trainees should learn the anatomyof the airway through study of anatomic drawings andmodels. Trainees should learn airway assessment (seePeriprocedure assessment section) and learn recognitionof apnea and airway obstruction through experienceassessing ventilation in the endoscopy unit. An under-standing of capnography can be gained from instructionavailable in the literature, and training should includereal-time interpretations of capnographic waveforms inthe endoscopy unit if capnography is used in the unit.Didactic training is necessary for pharmacologic agentsthat are not covered in ACLS or are used in endoscopyoutside their roles in emergencies. These include nalox-one, flumazenil, agents for hypotension and hypertension,and the use of atropine (glycopyrrolate or vagolyticagents) for vasovagal reactions.

Specific maneuvers for opening the airway should bepracticed initially on models, including the head-tilt,

chin lift, or jaw-thrust maneuvers; placement of naso-

pharyngeal and oropharyngeal airways; and bag maskventilation.

Specific elements of training should include the following:

1. Didactic session on risk factors for aspiration duringendoscopy and prevention of aspiration

2. Didactic sessions and study of written materials onairway anatomy, airway assessment, and identificationof impaired and absent ventilation

3. ACLS certification including hands-on airway training4. Didactic training in the significance of hypoxemia with

reference to ventilation in patients using and not usingsupplemental oxygen

5. Didactic training in the use of supplemental oxygen toprevent and treat hypoxemia

6. The head-tilt and jaw-thrust maneuvers, placement ofa nasopharyngeal airway, oropharyngeal airway, bag-mask ventilation, and laryngeal mask airway should bepracticed on models.

7. Didactic training in the use of reversal agents for opi-oids and benzodiazepines

8. Didactic training in the use of intravenous agents forbradycardia, hypotension, and hypertension

Assessment of CompetenceCompetence should be assessed by completion of

the ACLS examination, by a written examination coveringissues not addressed by ACLS (including aspiration risk,recognition of compromised ventilation, hypoxemia-ven-tilation relationship, use of reversal agents, use of intra-venous medications for hypotension and hypertension),by demonstration of techniques to open the airway onmodels, and by assessment of trainee’s ability to preventaspiration, assess airway risk, and manage airway compro-mise and other sedation complications promptly and ap-propriately.

Anesthesiologist Assistance forEndoscopic ProceduresImportanceMany factors may contribute to the decision to

have anesthesiologist-directed sedation for endoscopicprocedures. Procedure-related factors include pro-longed procedures requiring deep sedation and/or gen-eral anesthesia. Patient-related factors are also impor-tant. Chief among these are increasing levels of adversephysiology and uncooperative patients. An ASA Physi-cal Status of 4 or greater has been associated with anincreased risk of cardiopulmonary complications. Theuse of sedatives, analgesics, and alcohol can also in-crease sedation-related risk (Table 4).

Goals of TrainingDuring training, trainees should gain an under-

standing of the following:

1. Didactic training in the recognition of clinical condi-

tions, history, and physical findings that may predis-

2

3

R

L

R

R

R

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pose to increased risk of cardiopulmonary complica-tions with standard sedation (Table 4).

. Didactic and clinical training in the use of Mallampaticlassification.

. Didactic and clinical training in ASA physical statusassessment

Training Process

The training process will involve didactic lecturesas well as clinical instruction and demonstration.

Assessment of CompetenceCompetence should be assessed during clinical

training as well as by a part of a comprehensive writtenexamination.

Intraprocedureal MonitoringIt is the responsibility of the nurse to monitor the

patient’s vital signs, comfort, and clinical status. In addi-tion, an individual other than the physician performingthe endoscopy, such as a nurse, needs to possess the skillsnecessary to recognize and intervene in the event thatadverse events occur during the endoscopic procedure. Itis imperative that the physician-nurse team maintain on-

Table 4. Guidelines for Anesthesiology Assistance During GIEndoscopy

Prolonged or therapeutic endoscopic procedures requiring deepsedation or general anesthesia

Anticipated intolerance, paradoxical reaction or allergy to standardsedation regimens

Increased risk of complications because of severe comorbidity (ASAclass 4 and higher)

Increased risk of airway obstructionHistory of stridorHistory of severe sleep apneaDysmorphic facial features

Trisomy 21Pierre-Robin syndrome

Oral abnormalities�3 cm oral opening in adultsProtruding incisorsMacroglossiaHigh arched paletteTonsillar hypertrophyMallampati score of 4

Neck abnormalitiesDecreased hyoid-mental distance (�3 cm in adults)Short thick neckLimited neck extensionCervical spine disease (eg, advanced rheumatoid arthritis) or

traumaSevere tracheal deviation

Jaw abnormalitiesRetrognathiaMicrognathiaTrismusSevere malocclusion

ASA, American Society of Anesthesiologists.

going communication throughout the procedure to opti- *

mize the early recognition and treatment of cardiopulmo-nary events.

Minimal monitoring requirements recommended forthe patient receiving moderate sedation and analgesia areperiodic assessment of blood pressure and continuousassessment of cardiac rhythm and rate, ventilation, oxy-genation, level of consciousness, and pain. The combina-tion of observation and electronic monitoring provides athorough method of patient assessment. Electronic de-vices that are useful are pulse oximetry, electronic bloodpressure devices, continuous electrocardiogram monitor-ing, and capnography. In a recent publication regardingStandards for Basic Anesthetic monitoring, the ASAHouse of Delegates states “During moderate or deep se-dation the adequacy of ventilation shall be evaluated bycontinual observation of qualitative clinical signs andmonitoring for the presence of exhaled carbon dioxideunless precluded or invalidated by the nature of the pa-tient, procedure, or equipment.”

It should be noted that the only evidence suggestingthat capnography may be of benefit are in adults under-going prolonged procedures such as ERCP and EUS andin the pediatric population undergoing upper endoscopyand colonoscopy. Currently, there are no data showing abenefit of capnography in adults undergoing upper en-doscopy or colonoscopy. It is to be determined whetherthis will become a standard requirement for future endo-scopic practice.

The nurse should be familiar with all of the monitoringequipment. Presedation equipment evaluation is neces-sary to validate its functionality.

It is important to monitor the level of consciousness ofthe patient. Many clinical scoring systems have been de-veloped to assist in determining the level of sedation andpatient responsiveness, such as the Modified ObserversAssessment of Alertness and Sedation score and the Ram-say score (Tables 2 and 5). These are useful tools for thetitration of medications throughout the procedure.

Bispectral index (BIS) monitoring may be anothertool used in the care of patients undergoing sedatedprocedures. This enables the clinician to monitor a

Table 5. Modified Observer’s Assessment ofAlertness/Sedation Scale

Responsiveness Numerical score

esponds readily to name spoken innormal tone

5

ethargic response to name spokenin normal tone

4

esponds only after name is calledloudly and/or repeatedly

3

esponds only after mild prodding orshaking

2

esponds only after painful trapeziussqueeze*

1

o response after painful trapeziussqueeze

0

Purposeful response, not withdrawal.

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patient’s level of consciousness. The BIS monitor useselectroencephalographic waveforms to measure con-sciousness. Currently, there are no data supporting therole of BIS monitoring during procedure sedation forGI endoscopy.

The nurse must be knowledgeable about the signifi-cance of the patient’s hemodynamic physiologic changes,ventilation and oxygenation status, and level of sedation.Pain assessments are needed throughout the procedure.This often poses a challenge in the sedated patient. Visualcues of discomfort and the knowledge and use of variouspain scales are helpful to evaluate a patient’s comfortstatus.

Communication between the nurse and endoscopist isexpected if any of the patient needs or physiologic param-eters change. Complete documentation of the assess-ments and monitoring data is imperative during the se-dation process. It is required that documentation occursat regular intervals throughout the procedure.

Goals of TrainingThe trainee should learn the necessary compo-

nents of intraprocedure monitoring. This would generallyinclude the following competencies:

1. State the necessary monitoring requirements for a pa-tient undergoing procedure sedation

2. Demonstrate the proper use of monitoring toolsduring sedation: noninvasive blood pressure devices,pulse oximetry, electrocardiographic monitoring,and capnography

3. Document required vital signs and monitoring.4. Identify and document the sedation scale used during

the procedure

Training ProcessTraining in physiologic monitoring should include

familiarity with equipment and troubleshooting shouldthere be dysfunction of the physiologic monitoring equip-ment. Once this baseline core competency is completed,training with equipment during GI endoscopic proce-dures should ensue. Trainees should gain experience andinterpretation of physiologic monitoring values and dem-onstrate the appropriate intervention should alarm valuesbe noted. Additionally, the trainee should demonstratethe ability to periodically assess the level of consciousnessof patients during procedure sedation.

Assessment of CompetenceThe assessment of competence with intraproce-

dure monitoring should be assessed as part of theoverall evaluation of trainees in their GI endoscopytraining during the fellowship. Questions related tointraprocedure monitoring should be included on theboard examination and should reflect a general knowl-

edge of this competency.

Postprocedure Assessment TrainingImportanceAs with intraprocedure monitoring, the contin-

uum of physiologic monitoring and its importance indetermining physiologic recovery as well as early identifi-cation of oversedation should be emphasized.

In the postprocedure area, the recovery of physiologic andbasic functional parameters as outlined by basic postsurgicaland anesthesia grading schemes should be emphasized.

The trainee should learn the appropriate standards ofpostprocedure monitoring and predischarge assessmentand understand the risk of postprocedure sedation-re-lated complications of procedure sedation. This shouldinclude the following:

1. The importance of periodic assessment of vital signs.This should include blood pressure, pulse, oximetry,and, in selected situations, electrocardiography.

2. The indications, contraindications, dosing, and sideeffects of reversal agents such as flumazenil and nal-oxone. The risk of resedation must also be addressed.

3. Pain assessment according to established institutionalprotocols

4. Familiarity with the assessment of the level of con-sciousness according to an established grading system(ie, Ramsay or Modified Observers Assessment of Alert-ness and Sedation score; see Tables 2, 5).

5. Familiarity with a standardized discharge assessmentscoring system such as the Post-Anesthetic DischargeScoring System or the Aldrete score (Tables 6,7).

6. Familiarity with verbal and written instructions outliningdiet, activity, medication, and follow-up instructions. Pa-tients who have received any sedation must have an adultescort and may not drive themselves home.

Table 6. Aldrete Score

Respiration2 � Able to take deep breath and cough1 � Dyspnea/shallow breathing0 � Apnea

Oxygen saturation2 � Maintains �92% on room air1 � Needs O2 inhalation to maintain O2 saturation �90%0 � Saturation �90% even with supplemental oxygen

Consciousness2 � Fully awake1 � Arousable on calling0 � Not responding

Circulation2 � BP �20 mm Hg preprocedurally1 � BP �20-50 mm Hg preprocedurally0 � BP �50 mm Hg preprocedurally

Activity2 � Able to move 4 extremities1 � Able to move 2 extremities0 � Able to move 0 extremities

Total score is 10. Patients scoring �8 (and/or are returned to similarpreoperative status) are considered fit for transition to phase II recov-ery.

BP, Blood pressure.

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Goals of TrainingDuring training, trainees should gain an under-

standing of and demonstrate operational competency inthe following:

1. Didactic training in the recognition of clinical condi-tions, history, and physical findings that may predis-pose to increased risk of cardiopulmonary complica-tions with standard sedation. (Table 1).

2. Didactic and clinical training in the use of Mallampaticlassification. In patients receiving anesthesia-assistedsedation, an increased Mallampati score has beenshown to be a risk factor for the need for anesthesia-directed airway manipulation. There are no similardata for endoscopic sedation targeting moderate seda-tion (Fig. 1).

3. Didactic and clinical training in the ASA physical statusclassification assessment.

Training ProcessThe training process will involve didactic lectures

as well as clinical instruction and demonstration. Traineesmust demonstrate proficiency in the interpretation ofphysiologic monitoring data as well as recovery assess-ment. This experience should include the cognitive andtechnical aspects of physiologic monitoring. In addition,the use of extended monitoring devices such as capnog-raphy should be considered in those instances in whichdeep sedation is targeted or direct observation of thepatient’s respiratory activity cannot be obtained.

Assessment of CompetenceKnowledge of procedure monitoring and recovery

assessment should be assessed as part of the overall evalua-tion trainees in gastroenterology. Questions relating to phys-iologic monitoring should be included on the board exam-ination and should reflect general knowledge of this content.

Table 7. Postanesthetic Discharge Scoring System

Vital signs2 � Within 20% of preoperative value1 � 20%-40% of preoperative value0 � �40% of preoperative value

Activity and mental status2 � Oriented � 3 and steady gait1 � Oriented � 3 or steady gait0 � Neither threshold is reached

Pain, nausea, and/or vomiting2 � Minimal1 � Moderate, having required treatment0 � Severe, requiring treatment

Bleeding2 � Minimal1 � Moderate0 � Severe

Intake and output2 � Has had oral fluids and voided1 � Has had oral fluids or voided0 � Neither

Total score is 10; �9 considered for discharge.

Endoscopy in Pregnant and LactatingWomenImportanceThe safety and efficacy of GI endoscopy during preg-

nancy is not well studied. The fetus is particularly sensitive tomaternal hypoxemia and hypotension that can potentiallylead to fetal compromise. It is therefore imperative to knowthe potential risks to the fetus and to balance these riskswith clear indications when endoscopic intervention is nec-essary. Additionally, caution needs to be exercised with theuse of certain medications because they may be transferredto the infant from the breast milk.

Goals of Training

1. Knowledge of the indications for and contraindicationsto endoscopy during pregnancy. This should include atrimester-specific approach to the procedure wheneverpossible, patient positioning, minimal radiation expo-sure, and the use of obstetric support (Tables 8,9).

. Knowledge of the safety of commonly used medica-tions for endoscopy during pregnancy. This shouldinclude sedation and reversal agents, topical anesthet-ics, antispasmodics, antibiotics, and colon-cleansingagents (Tables 10, 11).

3. Knowledge of which medications can be transferred toa breastfeeding infant (Table 12).

Training ProcessA combination of cognitive/clinical skills and knowl-

edge in the setting of endoscopic training is necessary for train-ing in the care of women who are pregnant or lactating.

Table 8. Indications for Endoscopy During Pregnancy

1. Significant or continued GI bleeding2. Severe or refractory nausea and vomiting or abdominal pain3. Dysphagia or odynophagia4. Strong suspicion of a colonic mass5. Severe diarrhea with a negative evaluation6. Biliary pancreatitis, choledocholithiasis, or cholangitis7. Biliary or pancreatic ductal injury

Table 9. General Principles Guiding Endoscopy DuringPregnancy

1. Always have a strong indication, particularly in high-riskpregnancies

2. Delay endoscopy until the second trimester whenever possible3. Use the lowest effective dose of sedative medications4. Wherever possible, use category A or B drugs5. Minimize procedure time6. Position patients in left pelvic tilts or left lateral position to avoid

vena caval or aortic compression7. Presence of fetal heart sounds should be confirmed before

procedure is begun and after the endoscopic procedure8. Obstetric support should be available in the event of a pregnancy-

related complication9. Endoscopy is contraindicated in obstetric complications such as

placental abruption, imminent delivery, rupture of membranes,

and eclampsia

F

FNBFPSGTC

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Assessment of CompetenceKnowledge of endoscopy in pregnant and lactating

women should be assessed as a part of an overall evalua-tion of trainees in gastroenterology during and after thefellowship. Questions relating to this topic should beincluded in the board examination and should reflect ageneral knowledge of this content.

Assessment of Competency inEndoscopic SedationImportanceThe assessment of competency is of critical impor-

tance during training in procedure sedation and monitor-

Table 10. U.S. FDA Categories for Drugs Used in Pregnancy

Category Description

A Adequate, well-controlled studies in pregnant women havenot shown an increased risk of fetal abnormalities

B Animal studies have revealed no evidence of harm to thefetus; however, there are no adequate or well-controlledstudies in pregnant women

orAnimal studies have shown an adverse effect, but

adequate and well-controlled studies in pregnantwomen have failed to demonstrate a risk to the fetus

C Animal studies have shown an adverse effect and thereare no adequate or well-controlled studies in pregnantwomen

orNo animal studies have been conducted, and there are no

adequate and well-controlled studies in pregnantwomen

D Adequate well-controlled or observational studies inpregnant women have demonstrated a risk to the fetus;however, the benefits of therapy may outweigh thepotential risk

X Adequate well-controlled or observational studies inanimals or pregnant women have demonstratedpositive evidence of fetal abnormalities; use of theproduct is contraindicated in women who are or maybecome pregnant

DA, Food and Drug Administration.

Table 11. U.S. FDA Categories for Drugs Used DuringEndoscopy

Medication FDA Category

Meperidine Bentanyl Caloxone Benzodiazepines Dlumazenil Cropofol Bimethicone Clucagon Bopical anesthetics Bolonoscopy preparationsPEG solutions CSodium phosphate/biphosphate CSodium phosphate/bisphosphate enemas C

DA, Food and Drug Administration; PEG, polyethylene glycol.

ing during GI endoscopy. Whenever possible, basic knowl-edge such as pharmacology and the use of physiologicmonitoring should be established before the trainee isplaced in the environment of the procedure room. The useof simulators and Web-based programs that are designedto assess technical and cognitive abilities should be usedwhenever possible. After demonstration of this knowl-edge, the trainee then continues with training in theprocedure room environment.

Goals of TrainingAs listed in Table 13, there are many types of

competencies that need to be addressed including medicalknowledge, practical competencies, interpersonal andcommunication skills, patient care, professionalism, prac-tice-based learning improvement, and systems-basedlearning. This is based on the competency evaluationprocess as outlined by the American Board of internalMedicine and currently used in gastroenterology fellow-ship programs.

It should be noted that the attainment of competency

Table 12. Breastfeeding Recommendations for MedicationsUsed During Endoscopy

MedicationSecreted intobreast milk Recommendations

Midazolam Yes Refrain from nursing for atleast 4 h afteradministration

Fentanyl Yes Secreted in very lowconcentrations;considered safe forbreastfeeding

Meperidine Yes Detectable up to 24 hafter administration;although consideredcompatible withbreastfeeding, fentanylshould be used whenpossible

Propofol Yes Excreted into breast milkfor 4-5 h afteradministration;continued breastfeedingafter exposure is notrecommended; length ofprohibition notdetermined

Penicillin/cephalosporins

Yes Trace amounts excreted;considered compatiblewith breastfeeding

Quinolones Yes Potential for arthropathy inthe infant; should beavoided

Sulfonamides Yes Contraindicated in nursinginfants �2 months ofage; avoid if infant ispremature, ill, or hasglucose-6-phosphatedehydrogenasedeficiency

is not a static process. It is not infrequent that a trainee

Sup

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who is taken out of a learning environment for some timemay exhibit decrement in a previously achieved compe-tency. It is recommended therefore that exposure to pro-cedure sedation and GI endoscopy is continued on aregular basis so that competencies can be conserved.

Principles of Assessment

1. Assessment should be linked to learning goals andcompletion of learning modules.

2. Learning environment and evaluation should be ofhigh quality.

3. Evaluation should be timely, reliable, transparent, en-gaging, and efficient.

Proposed Mechanisms for Assessment

1. Web-based interactive instructional modules or work-book with the opportunity to present information in astructured fashion that will engage the learner andbuild on existing knowledge.

2. Web-based objective examination for medical knowledge.3. Web-based patient simulations/clinical scenarios to

test application of knowledge to simple and complexsituations.

4. Development of feedback tools, audit blueprints, andportfolio guides for other competencies for use by localmedical staffs.

5. Mechanism for certification of successful completionof training process for presentation to privileging com-mittees (for staff) or program directors (for trainees).

Supplementary Material

Note: To access the supplementary material

Table 13. Competencies and Assessment Tools

Competencies to be evaluated

Medical knowledgeIndications and contraindicationsPrinciples of airway managementAvailable agents (pharmacology, dosing, administration

intervals, antagonists)Practical competencies

WC

ACLS protocols (PALS if pediatric patients treated)Proficiency in airway managementInterpersonal and communication skillsInformed consent process

DP

Patient careApplication of techniques to clinical scenarios, complications

W

Professionalism M

Practice-based learning and improvement MSystems-based practice M

PQ

ACLS, Advanced Cardiac Life Support; PALS, Pediatric Advanced Life

accompanying this article, visit the online version of

Gastroenterology at www.gastrojournal.org, and at http://dx.doi.org/10.1053/j.gastro.2012.05.001.

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659-63.

23. Green SM, Li J. Ketamine in adults: what emergencyphysicians need to know about patient selection andemergence reactions. Acad Emerg Med 2000;7:278-81.

24. Greenblatt DJ, Abernethy DR. Midazolam pharmacol-ogy and pharmacokinetics. Anesth Rev 1985;12:17-20.

25. Hall JE, Uhrich TD, Barney JA, et al. Sedative, amnes-tic, and analgesic properties of small-dose dexmedeto-midine infusions. Anesth Analg 2000;90:699-705.

26. Hara M, Kai Y, Ikemoto Y. Propofol activates GABA Areceptor-chloride ionophore complex in dissociatedhippocampal pyramidal neurons of the rat. Anesthe-siology 1993;79:781-8.

27. Precedex (dexmedetomidine hydrochloride) injectionfor infusion (following dilution). FDA Medwatch safetyinformation and adverse event reporting program.Available at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm172364.htm. Accessed November 12,2011.

28. Jalowiecki P, Rudner R, Gonciarz M, et al. Sole use ofdexmedetomidine has limited utility for conscioussedation during outpatient colonoscopy. Anesthesiol-ogy 2005;103:269-73.

29. Jasinski DR, Martin WR, Haertzen CA. The humanpharmacology and abuse potential of N-allylnoroxy-morphone (naloxone). J Pharmacol Exp Ther 1967;157:420-6.

30. Kankaria A, Lewis JH, Ginsberg G, et al. Flumazenilreversal of psychomotor impairment due to midazo-lam or diazepam for conscious sedation for upperendoscopy. Gastrointest Endosc 1996;44:416-21.

31. Kanto JH. Midazolam: the first water-soluble benzo-diazepine. Pharmacology, pharmacokinetics and effi-cacy in insomnia and anesthesia. Pharmacotherapy1985;5:138-55.

32. Kirberg A, Sagredo R, Montalva G, et al. Ketamine forpediatric endoscopic procedures and as a sedationcomplement for adult patients. Gastrointest Endosc2005;61:501-2.

33. Lebrun HI. Neurleptanalgesia in upper alimentaryendoscopy. Gut 1976;17:655-8.

34. Lee MG, Hanna W, Harding H. Sedation for uppergastrointestinal endoscopy: a comparative study ofmidazolam and diazepam. Gastrointest Endosc 1989;35:82-4.

35. Maslekar SK, Hughes M, Skinn E, et al. Randomisedcontrolled trial of sedation for colonoscopy: entonoxversus intravenous sedation. Gastrointest Endosc2006;63:AB97.

36. Mather LE, Tucker GT, Pflug AE, et al. Meperidinekinetics in man. Intravenous injection in surgical pa-tients and volunteers. Clin Pharmacol Ther 1975;17:21-30.

37. Moore TJ, Walsh CS, Cohen MR. Reported adverseevent cases of methemoglobinemia associated withbenzocaine products. Arch Intern Med 2004;164:

1192-6.

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38. Morcos WE, Payne JP. The induction of anaesthesiawith propofol (Diprivan) compared in normal andrenal failure patients. Postgrad Med J 1985;61:62-3.

39. Mordel A, Winkler E, Almog S, et al. Seizures afterflumazenil administration in a case of combined ben-zodiazepine and tricyclic antidepressant overdose.Crit Care Med 1992;20:1733-4.

40. Moser JD, Caldwell JB, Rhule FJ. No more than nec-essary: safety and efficacy of low-dose promethazine.Ann Pharmacother 2006;40:45-8.

41. Nordt SP, Clark RF. Midazolam: a review of thera-peutic uses and toxicity. J Emerg Med 1997;15:357-65.

42. Paspatis GA, Manolaraki M, Xirouchakis G, et al.Synergistic sedation with midazolam and propofolversus midazolam and pethidine in colonoscopies: aprospective, randomized study. Am J Gastroenterol2002;97:1963-7.

43. Patel D, Chopra S, Berman MD. Serious systemictoxicity resulting from use of tetracaine for pharyn-geal anesthesia in upper endoscopic procedures. DigDis Sci 1989;34:882-4.

44. Reimann FM, Samson U, Derad I, et al. Synergisticsedation with low-dose midazolam and propofol forcolonoscopies. Endoscopy 2000;32:239-44.

45. Reves JG, Fragen RJ, Vinik HR, et al. Midazolam:pharmacology and uses. Anesthesiology 1985;62:310-24.

46. Reves JG, Glass PS, Lubarsky DA, et al. Intravenousnonopioid anesthetics. In: Miller RD, editor. Miller’sanesthesia. Philadelphia (Pa): Elsevier Churchill Liv-ingstone; 2005. p. 317-78.

47. Robb ND, Hargrave SA. Tolerance to intravenousmidazolam as a result of oral benzodiazepine therapy:a potential problem for the provision of conscioussedation in dentistry. Anesth Pain Control Dent 1993;2:94-7.

48. Saunders BP, Fukumoto M, Halligan S, et al. Patient-administered nitrous oxide/oxygen inhalation pro-vides effective sedation and analgesia for colonos-copy. Gastrointest Endosc 1994;40:418-21.

49. Stack CG, Rogers P, Linter SP. Monoamine oxidaseinhibitors and anaesthesia. A review. Br J Anaesth1988;60:222-7.

50. Stark RD, Binks SM, Dutka VN, et al. A review of thesafety and tolerance of propofol (Diprivan). PostgradMed J 1985;61(Suppl 3):152-6.

51. Struys MM, Vanluchene AL, Gibiansky E, et al. Aqua-van injection, a water-soluble prodrug of propofol asa bolus injection: a phase I dose-escalation compari-son with diprivan (part 2). Pharmacodynamics andsafety. Anesthesiology 2005;103:730-43.

52. Szabadi E, Bradshaw CM, Freeman C, et al. The his-taminergic system of the brain: its roles in arousaland autonomic regulation. NeuropsychopharmacolHung 2004;6:163-4.

53. Thomas VL, Sutton DN, Saunders DA. The effect offentanyl on propofol requirements for day case an-

aesthesia. Anaesthesia 1988;43:73-5.

54. Tu RH, Grewall P, Leung JW, et al. Diphenhydramineas an adjunct to sedation for colonoscopy: a double-blind randomized, placebo-controlled study. Gastro-intest Endosc 2006;63:87-94.

55. Watcha MF, White PF. New antiemetic drugs. IntAnesthesiol Clin 1995;33:1-20.

56. White PF, Way WL, Trevor AJ. Ketamine–its pharma-cology and therapeutic uses. Anesthesiology 1982;56:119-36.

57. White PF. Propofol pharmacokinetics and pharmaco-dynamics. Semin Anesth 1988;7:4-20.

58. Wilcox CM, Forsmark CE, Cello JP. Utility of dro-peridol for conscious sedation in gastrointestinalendoscopic procedures. Gastrointest Endosc 1990;36:112-5.

59. Wille RT, Chaffee BW, Ryan ML, et al. Pharmacoeco-nomic evaluation of flumazenil for routine outpatientEGD. Gastrointest Endosc 2000;51:282-7.

60. Willie RT, Barnett JL, Chey WD, et al. Routine dro-peridol premedication improves sedation for ERCP.Gastrointest Endosc 2000;52:362-6.

61. Yimchareon P, Fogel E, Kovacs R, et al. Droperidol,when used for sedation during ERCP, may prolongthe QT interval. Gastrointest Endosc 2006;63:979-85.

62. Young D. FDA advisory panel discusses droperidolconcerns. Am J Health Syst Pharm 2004;61:219-22.

Informed Consent for Endoscopic Sedation

1. Berg JW, Appelbaum PS, Lidz CW, et al. Informedconsent: legal theory and clinical practice. Oxford(UK): Oxford University Press; 2001.

2. Canterbury v. Spence, 464 F.2d 772, 150 U.S.App.D.C.263 (D.C.Cir.1972).

3. Feld AD. Informed consent for colonoscopy. In: WayneJ, Rex DK, Williams CB, editors. Colonoscopy: princi-ples and practice. Malden (Mass): Blackwell Publishing;2009. p. 79-89.

4. Feld AD. Informed consent: not just for proceduresanymore. Am J Gastroenterol 2004;99:979-80.

5. Feld KA, Feld AD. Legal issues and risk managementfor colonoscopy. Gastrointest Endosc Clin N Am 2010;20:593-601.

6. Richards EP, Rathbun KC. Consent to medical treat-ment. In: Medical care law. Gaithersburg (Md): AspenPublications; 1999:205-47.

7. Schloendorff v. Society of New York Hospital, 211 N.Y.125, 105 N.E. 92 (N.Y. 1914).

Periprocedure Assessment for EndoscopicProcedures

1. American Society for Gastrointestinal Endoscopy andSociety of Gastrointestinal Nurses and Associates. JointPosition Statement Role of GI Registered Nurse in theManagement of Patients undergoing Sedated Proce-

dures 2004. Available at: www.sgna.org/Portals/0/

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Education/Position%20Statements/ASGESGNASedationPositionStatement.pdf. Accessed November12, 2011.

2. American Society of Anesthesiologist. Statement onGranting Privileges for Administration of ModerateSedation to Practitioners who are not Anesthesia Pro-fessionals 2006. Available at: www.asahq.org/Search.aspx?q�moderate�sedation&site�All. Accessed No-vember 12, 2011.

3. American Society of Anesthesiologists Standards andPractice Parameters Committee. Standards for BasicAnesthetic Monitoring 2011. Available at: www.asahq.org/For-Members/Clinical-Information/Standards-Guidelines-and-Statements.aspx. AccessedNovember 12, 2011.

4. Arrowsmith JB, Gertsman BB, Fleischer DE, et al.Results from the American Society for Gastrointesti-nal Endoscopy/U.S. Food and Drug Administrationcollaborative study on complication rates and druguse during gastrointestinal endoscopy. GastrointestEndosc 1991;37:421-7.

5. Chernik DA, Gillings D, Laine H, et al. Validity andreliability of the Observer’s Assessment of Alertness/Sedation Scale: study with intravenous midazolam.J Clin Psychopharmacol 1990;10:244-51.

6. Fisher L, Fisher A, Thomson A. Cardiopulmonarycomplications of ERCP in older patients. GastrointestEndosc 2006;63:948-55.

7. Gangi S, Saidia F, Patel K, et al. Cardiovascular com-plications after GI endoscopy: occurrence and risks ina large hospital system. Gastrointest Endosc 2004;60:679-85.

8. Malviya S, Voepel-Lewis T, Tait AR. Adverse eventsand risk factors associated with sedation of chil-dren by non-anesthesiologists. Anesth Analg 1997;85:1207-13.

9. Mitty RD, Wild DM. The pre- and postprocedureassessment of patients undergoing sedation for gas-trointestinal endoscopy. Gastrointest Endosc ClinN Am 2008;18:627-40.

0. Quine MA, Bell GD, McCloy RF, et al. Prospectiveaudit of upper gastrointestinal endoscopy in two re-gions of England: safety, staffing, and sedation meth-ods. Gut 1995;36:462-7.

1. Riphaus A, Stergiou N, Wehrmann T. Sedation withpropofol for routine ERCP in high-risk octogenari-ans: a randomized controlled study. Am J Gastroen-terol 2005;100:1957-63.

2. Sharma VK, Nguyen CC, Crowell MD, et al. A na-tional study of cardiopulmonary unplanned eventsafter GI endoscopy. Gastrointest Endosc 2007;66:27-34.

3. Silvis SE, Nebel O, Rogers G, et al. Endoscopic com-plications. Results of the 1974 American Society forGastrointestinal Endoscopy survey. JAMA 1976;235:928-30.

4. Society of Gastrointestinal Nurses and Associates. Guide-

lines for Documentation in the Gastrointestinal Endos-

copy Setting 2003. Available at: www.sgna.org/Portals/0/Education/Practice%20Guidelines/DocumentationGuideline.pdf. Accessed November 12, 2011.

5. Society of Gastrointestinal Nurses and Associates.Role Delineation of the RN in a staff position inGastroenterology 2010. Available at: www.sgna.org/Portals/0/Education/Practice%20Guidelines/StandardsClinicalNursingPractice.pdf. Accessed No-vember 12, 2011.

6. Waring JP, Baron TH, Hirota WK, et al. ASGEStandards of Practice Committee. Guidelines forconscious sedation and monitoring during gastro-intestinal endoscopy. Gastrointest Endosc 2003;58:317-22.

Levels of Sedation

1. Gross JB, Bailey PL, Caplan RA, et al., American Societyof Anesthesiologists Task Force on Sedation and An-algesia by Non-Anesthesiologists. Practice guidelinesfor sedation and analgesia by non-anesthesiologists.Anesthesiology 2002;96:1004-17.

2. Joint Commission Resources, Organizations. New def-initions, revised standards address the continuum ofsedation and anesthesia. Jt Comm Perspect 2000;20:5-10.

3. Patel S, Vargo JJ, Khandwala F, et al. Deep sedationoccurs frequently during elective endoscopy with me-peridine and midazolam. Am J Gastroenterol 2005;100:2689-95.

Training in the Administration of SpecificAgents for Moderate Sedation

1. Centers for Medicare & Medicaid Services, Depart-ment of Health and Human Services, January 14,2011. CMS Manual System, Department of Health &Human Services (DHHS). Pub. 100-07 State Opera-tions Provider Certification.

2. Clarke AC, Chiragakis L, Hillman LC, et al. Seda-tion for endoscopy: the safe use of propofol bygeneral practitioner sedationists. Med J Aust 2002;176:158-61.

3. Cohen LB, Dubovsky AN, Aisenberg J, et al. Propofolfor endoscopic sedation: a protocol for safe and ef-fective administration by the gastroenterologist. Gas-trointest Endosc 2003;58:725-32.

4. Cohen LB, Hightower CD, Wood DA, et al. Moderatelevel sedation during endoscopy: a prospective studyusing low-dose propofol, meperidine/fentanyl, andmidazolam. Gastrointest Endosc 2004;59:795-802.

5. Cohen LB, Wecsler JS, Gaetano JN, et al. Endoscopicsedation in the United States: results from a nation-wide study. Am J Gastroenterol 2006;101:967-74.

6. Dumonceau JM, Riphaus A, Aparicio JR, et al. NAAPTask Force Members. European Society of Gastroin-testinal Endoscopy, European Society of Gastroenter-ology and Endoscopy Nurses and Associates, and the

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anesthesiologist administration of propofol for GIendoscopy. Endoscopy 2010;42:96-112.

7. Fanti L, Agostoni M, Casati A, et al. Target-controlledpropofol infusion during monitored anesthesia inpatients undergoing ERCP. Gastrointest Endosc2004;60:361-6.

8. Fechner J, Ihmsen H, Schiessel C, et al. Sedation withGPI 15715, a water soluble prodrug of propofol, us-ing a target-controlled infusion in volunteers. AnesthAnalg 2005;100:701-6.

9. Froelich F, Harris JK, Wietslisbach V, et al. Currentsedation and monitoring practice for colonoscopy: aninternational observational study (EPAGE). Endos-copy 2006;38:461-9.

0. Heuss LT, Schieper P, Drewe J, et al. Risk stratificationand safe administration of propofol by registerednurses supervised by the gastroenterologist: a pro-spective observational study of more than 2000 cases.Gastrointest Endosc 2003;57:664-71.

1. Koshy G, Nair S, Norkus EP, et al. Propofol versusmidazolam and meperidine for conscious sedation inGI endoscopy. Am J Gastroenterol 2000;95:1476-9.

2. Lichtenstein DR, Jagannath S, Baron TH, et al. Seda-tion and anesthesia in GI endoscopy. GastrointestEndosc 2008;68:205-16.

3. Pambianco DJ, Vargo JJ, Pruitt RE, et al. Computer-assisted personalized sedation for upper endoscopyand colonoscopy: a comparative, multicenter ran-domized study. Gastrointest Endosc 2011;73:765-72.

4. Pambianco DJ, Whitten CJ, Moerman A, et al. Anassessment of computer-assisted personalized seda-tion: a sedation delivery system to administer propo-fol for gastrointestinal endoscopy. Gastrointest En-dosc 2008;68:542-7.

5. Qadeer MA, Vargo JJ, Khandwala F, et al. Propofolversus traditional agents for gastrointestinal endos-copy: a meta-analysis. Clin Gastroenterol Hepatol2005;3:1049-56.

6. Rex DK, Deenadaylu VP, Eid E, et al. Endoscopist-di-rected administration of propofol: a worldwide safetyexperience. Gastroenterology 2009;137:1229-37.

7. Rex DK, Heuss LT, Walker JA, et al. Trained registerednurses/endoscopy teams can administer propofol safelyfor endoscopy. Gastroenterology 2005;129:1384-91.

8. Rex DK, Sipe BW, Kinser KM, et al. Safety of propofoladministered by registered nurses with gastroenterol-ogist supervision in 2,000 endoscopic cases. Am JGastroenterol 2002;97:1159-63.

9. Sipe BW, Rex DK, Latinovich D, et al. Propofol versusmidazolam/meperidine for outpatient colonoscopy:administration by nurses supervised by endoscopists.Gastrointest Endosc 2002;55:815-25.

0. Tohda G, Higashi S, Wakahara S, et al. Propofolsedation during endoscopic procedures: safe and ef-fective administration by registered nurses supervisedby endoscopists. Endoscopy 2006;38:360-7.

1. Ulmer BJ, Hansen JJ, Overly CA, et al. Propofol versus

midazolam/fentanyl for outpatient colonoscopy: ad-

ministration by nurses supervised by endoscopists.Clin Gastroenterol Hepatol 2003;1:425-32.

2. VanNatta ME, Rex DK. Propofol alone titrated todeep sedation versus propofol in combination withopioids and/or benzodiazepines and titrated to mod-erate sedation for colonoscopy. Am J Gastroenterol2006;101:2209-17.

3. Vargo JJ, Ahmad AS, Aslanian HR, et al; ASGE Train-ing Committee. Training in patient monitoring andsedation and analgesia. Gastrointest Endosc 2007;66:7-10. Erratum in: Gastrointest Endosc 2007;66:424;Gastrointest Endosc 2007;66:637; Savides, Thomas A[corrected to Savides, Thomas J].

4. Vargo JJ, Cohen LB, Rex DK, et al. Position statement:nonanesthesiologist administration of propofol forGI endoscopy. Am J Gastroenterol 2009;104:2886-92.

5. Vargo JJ, Cohen LB, Rex DK, et al. Position statement:nonanesthesiologist administration of propofol forGI endoscopy. Gastrointest Endosc 2009;70:1053-9.

6. Vargo JJ, Zuccaro G, Dumot J, et al. Gastroenterologist-administered propofol versus meperidine and midazo-lam for ERCP and EUS: a randomized, controlled trialwith cost effectiveness analysis. Gastroenterology 2002;123:8-16.

7. Walker JA, McIntyre RD, Scleinitz PF, et al. Nurse-administered propofol sedation without anesthesiaspecialists in 9152 endoscopic cases in an ambula-tory surgery center. Am J Gastroenterol 2003;98:1744-50.

8. Wehrmann T, Grotkamp J, Stergiou N, et al. Electro-encephalogram monitoring facilitates sedation withpropofol for routine ERCP: a randomized, controlledtrial. Gastrointest Endosc 2002;56:817-24.

9. Wehrmann T, Kokapick S, Lembcke B, et al. Efficacyand safety of intravenous propofol sedation for rou-tine ERCP: a prospective, controlled study. Gastroin-test Endsoc 1999;49:677-83.

0. Weston BR, Chadalawada V, Chalasani N, et al.Nurse-administered propofol versus midazolam andmeperidine for upper endoscopy in cirrhotic patients.Am J Gastroenterol 2003;98:2440-47.

1. Yusoff IF, Raymond G, Sahai AV. Endoscopist admin-istered propofol for upper-GI EUS is safe and effec-tive: a prospective study in 500 patients. GastrointestEndosc 2004;60:356-60.

Training in Airway/Rescue Techniques andManagement of Complications

1. Mallampati S, Gatt S, Gugino L, et al. A clinical sign topredict difficult tracheal intubation: a prospectivestudy. Can Anaesth Soc J 1985;32:429-34.

2. Nuckton TJ, Glidden DV, Browner WS, et al. Physicalexamination: Mallampati score as an independentpredictor of obstructive sleep apnea. Sleep 2006:29:

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Anesthesiologist Assistance for EndoscopicProcedures

1. Inadomi JM, Gunnarsson CL, Rizzo JA, et al. Projectedincreased growth rate of anesthesia professional-deliv-ered sedation for colonoscopy and EGD in the UnitedStates: 2009 to 2015. Gastrointest Endosc 2010;72:580-6.

2. Van der Linden P. Sedation in gastrointestinal en-doscopy: an anesthesiologist’s perspective. Digestion2010;82:102-5.

Intraprocedure Monitoring

1. Bell GD, Bown S, Morden A, et al. Prevention ofhypoxemia during upper gastrointestinal endoscopyby means of oxygen via nasal cannulae. Lancet 1987;1:1022-4.

2. Bell JK, Laasch HU, Wibraham L, et al. Bispectralindex monitoring for conscious sedation: better, safer,faster. Clin Radiol 2004;59:1106-13.

3. Bower AL, Ripepi A, Dilger J, et al. Bispectral indexmonitoring of sedation during endoscopy. Gastroin-test Endosc 2000;52:192-6.

4. Chen SC, Rex DK. An initial investigation of bispec-tral index monitoring as an adjunct to nurse-admin-istered propofol sedation for colonoscopy. Am J Gas-troenterol 2004;99:1081-6.

5. Davidson JAH, Hosie HE. Limitations of pulse oxim-etry: respiratory insufficiency–a failure of detection.BMJ 1993;307:372-3.

6. Griffin SM, Chung SCS, Leung JWC, et al. Effect ofintranasal oxygen on hypoxia and tachycardia duringendoscopic cholangiopancreatography. BMJ 1990;300:83-4.

7. Hutton P, Clutton-Brock T. The benefits and pitfallsof pulse oximetry. BMJ 1993;307:457-8.

8. Jurell KR, O’Connor KW, Slack J, et al. Effect ofsupplemental oxygen on cardiopulmonary changesduring gastrointestinal endoscopy. Gastrointest En-dosc 1994;40:665-70.

9. Koga I, Hamada Y, Terada T, et al. Degree of variationin cerebral tissue concentration index (TOI) and nor-malized tissue hemoglobin index (NTHI) measures bynear-infrared spectroscopy (NIRO-100). Anesthesiol-ogy 2005;103:A22.

10. Lightdale JR, Goldman DA, Feldman HA, et al. Mi-crostream capnography improves patient monitoringduring moderate sedation: a randomized, controlledtrial. Pediatrics 2006;117:1170-8.

11. Liu B, Yu H, Yin Y, et al. Prediction of depth ofsedation and anesthesia by a new entropy-based ENImonitorTM: a preliminary study. Anesthesiology 2005;103:A800.

12. Nelson DB, Freeman ML, Silvis SE, et al. A random-ized, controlled trial of transcutaneous carbon diox-ide monitoring during ERCP. Gastrointest Endosc

2000;51:288-95.

13. Pedersen T, Moller AM, Pedersen BD. Pulse oximetry forperioperative monitoring: systematic review of random-ized, controlled trials. Anesth Analg 2003;96:426-31.

14. Qadeer MA, Vargo JJ, Dumot JA, et al. Capno-graphic monitoring of respiratory activity improvessafety of sedation for endoscopic cholangiopancre-atography and ultrasonography. Gastroenterology2009;136:1568-76.

15. Shah N, Chitkara A, Miller J, et al. Motion inducedfailure rates of pulse oximeters (POs)–failure ratesand recovery times in human volunteers. Anesthesi-ology 2005;103:A881.

16. Sharma VK, Nguyen CC, Crowell MD, et al. Anational study of cardiopulmonary unplannedevents after GI endoscopy. Gastrointest Endosc2007;66:27-34.

17. Vargo JJ, Holub JL, Faigel DO, et al. Risk factors forcardiopulmonary events during propofol-mediatedupper endoscopy and colonoscopy. Aliment Pharma-col Ther 2006;24:955-63.

18. Vargo JJ, Zuccaro G, Dumot JA, et al. Automatedgraphic assessment of respiratory activity is superior topulse oximetry and visual assessment for the detectionof early respiratory depression during therapeutic upperendoscopy. Gastrointest Endosc 2002;55:826-31.

19. Zafar S, Ayappa I, Norman R, et al. Choice of oximeteraffects apnea-hypopnea-index. Chest 2005;127:80-8.

20. Zuccaro G, Radaelli F, Vargo J, et al. Routine use ofsupplemental oxygen prevents recognition of pro-longed apnea during endoscopy. Gastrointest Endosc2000;51:AB141.

Postprocedure Assessment Training

1. Aldrete JA, Kroulik D. A post anesthetic recovery score.Anesth Analg 1970;49:924-34.

Endoscopy in Pregnant and Lactating Women

1. Banerjee S, Dominitz JA, Fanelli RD, et al; ASGE Stan-dards of Practice Committee. Sedation and analgesia inGI endoscopy. Gastrointest Endosc 2008;68:815-26.

2. Quereshi W, Rajan E, Adler D, et al; ASGE Standards ofPractice Committee. ASGE guideline: guidelines forendoscopy in pregnant and lactating women. Gastro-intest Endosc 2005;61:357-62.

Assessment of Competency in EndoscopicSedation

1. Cohen LB, Delegge MH, Aisenberg J, et al. AGA Insti-tute review of endoscopic sedation. Gastroenterology2007;133:675-701.

2. Vargo JJ, Ahmad AS, Aslanian H, et al. ASGE TrainingCommittee. Guidelines for training in patient moni-toring and sedation and analgesia. Gastrointest Endosc

1998;48:669-71.

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Appendix: A Pharmacology Primer

OpioidsOpioids exert their pharmacologic effects by bind-

ing to opioid receptors that are present throughout thecentral nervous system and peripheral tissues. Chemicalstructure differences between these medications accountfor their differences in pharmacokinetic parameters andreceptor specificity and affinity.

Meperidine. The induction dose of meperidine forconscious sedation is 25 to 50 mg administered slowlyover 1 to 2 minutes. Additional doses of 25 mg may beadministered every 2 to 5 minutes until adequate sedationis achieved. Its onset of action is 3 to 6 minutes, and itsduration of effect ranges from 1 to 3 hours. The half-lifeof meperidine may be significantly prolonged in patientswith renal insufficiency, increasing the potential for neu-rotoxicity. For this reason, it is generally recommendedthat fentanyl be used for sedation in patients with signif-icant renal insufficiency. The major adverse effects asso-ciated with meperidine are respiratory depression and, toa lesser extent, cardiovascular instability. The use of abarbiturate or benzodiazepine with an opioid has a syn-ergistic effect on the risk of respiratory depression. At lowdoses, opioid-induced nausea and vomiting are not dosedependent. A neurotoxic reaction with myoclonus andconvulsions caused by the accumulation of normeperi-dine has been reported in patients with renal failure.

Fentanyl. Fentanyl is a synthetic opioid narcoticnd is structurally related to meperidine. The onset of actions 1 to 2 minutes and duration of effect is 30 to 60 minutes.he initial dose of fentanyl is usually 50 to 100 �g. Supple-

mental doses of 25 �g each may be administered every 2 to5 minutes until adequate sedation is achieved. A dose reduc-tion of 50% or more is indicated in the elderly. With repeateddosing or continuous infusion, fentanyl accumulates in skel-etal muscle and fat, and its duration of effect can beprolonged.

The major adverse effect associated with fentanyl ad-ministration is respiratory depression. Respiratory depres-sion may last longer than the analgesic effect of fentanyl.In large doses, fentanyl may induce chest wall rigidity andgeneralized hypertonicity of skeletal muscle.

Naloxone (opioid antagonist). Naloxone hydro-hloride is an opioid antagonist that antagonizes all ofhe central nervous system effects of the opioids, includ-ng ventilatory depression, excessive sedation, and analge-ia. It is ineffective for reversing the effects of nonopioidrugs such as benzodiazepines and barbiturates.Naloxone is commercially available at concentrations of

.2 mg/mL, 0.4 mg/mL, and 1 mg/mL. It is recommendedhat patients receive an initial dose of 0.2 to 0.4 mg0.5-1.0 �g/kg) intravenously every 2 to 3 minutes until

the desired response is attained. Supplemental doses maybe required after 20 to 30 minutes. The onset of actionafter intravenous naloxone is 1 to 2 minutes, and itshalf-life is 30 to 45 minutes. The administration of addi-

tional doses of naloxone may be required in patients i

receiving narcotics with a longer half-life. Patients receiv-ing naloxone should be monitored for an extended periodof time.

Clinical use of naloxone for rescue during GI endoscopy isbased on experience with naloxone in opiate overdose. Thereare no large prospective trials evaluating the use of naloxonefor rescue in the endoscopy suite. The use of naloxone is verysafe. Jasinski administered doses of naloxone as high as 24mg in 70-kg adults without any major side effect. However,nausea, vomiting, sweating, restlessness, and seizures havebeen reported. There should be a minimum of 2 hours ofobservation after administration of naloxome to ensure thatresedation does not occur.

Benzodiazepines. The pharmacologic effects ofenzodiazepines include anxiolysis, sedation, amnesia, an-iconvulsant activity, muscle relaxation, and anesthesia.he amnestic effect may persist after sedation has wornff. Benzodiazepines enhance activity of the inhibitoryeurotransmitter GABA by binding to the GABAA recep-or. The most common benzodiazepines used for endo-copic sedation are diazepam and midazolam.

Diazepam. Diazepam is used in combination withan opioid for endoscopic sedation, although with less fre-quency than is the benzodiazepine midazolam. The initialinduction dose for endoscopic procedures is 5 to 10 mg over1 minute. If required, additional doses may be administeredat 5-minute intervals. Dose reduction is required in debili-tated or elderly patients. In general, 10 mg intravenously issufficient for most endoscopic procedures, although asmuch as 20 mg may be necessary if a narcotic is not beingcoadministered. The major side effects of diazepam arecoughing, respiratory depression, and dyspnea. The respira-tory depressant effect of diazepam and other benzodiaz-epines is dose dependent and results from depression of thecentral ventilatory response to hypoxia and hypercapnea.Respiratory depression is more likely to occur in patientswith underlying respiratory disease or those receiving com-binations of a benzodiazepine and an opioid.

Midazolam. Midazolam is distinguished from diaz-pam by its more rapid onset of action and shorteruration of effect. After intravenous administration,he onset of effect for midazolam is 1 to 2 minutes, andeak effect is achieved within 3 to 4 minutes. Its dura-ion of effect is 15 to 80 minutes. Midazolam clearances reduced in the elderly, obese, and those with hepaticr renal impairment.Endoscopists prefer the use of midazolam to diazepam

ecause of its favorable pharmacologic profile. The initialntravenous dose in healthy adults younger than 60 yearsf age is 1 to 2 mg (or no more than 0.03 mg/kg) injectedver 1 to 2 minutes. Additional doses of 1 mg (or 0.2-0.3g) may be administered at 2-minute intervals until ad-

quate sedation is achieved. When midazolam is used withn opioid, a synergistic interaction occurs, and a reduc-ion in the dose of midazolam may be indicated. Patientslder than 60 and those with ASA physical status 3 orbove require a dose reduction of 20% or more. A total

ntravenous dose greater than 6 mg is usually not required

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for routine endoscopic procedures. Patients who are un-dergoing a prolonged endoscopic procedure and thosewith a benzodiazepine tolerance may require larger doses.

Cole performed a double-blind, randomized study thatcompared diazepam with midazolam for endoscopic seda-tion. Midazolam was found to be more potent and fasteracting, reducing the time required for the induction of se-dation an average of 2.5 minutes per procedure. Fewer ad-verse events, including respiratory depression, were reportedin the patients receiving midazolam. Midazolam demon-strated superior amnestic properties, and recovery was com-parable in the 2 groups. Lee et al evaluated midazolam versusdiazepam for sedation in 149 patients undergoing EGD.Midazolam was associated with better patient tolerance, lessthrombophlebitis, and more amnesia compared with diaze-pam. Recovery time was similar with midazolam anddiazepam.

The major side effect of midazolam is respiratory depres-sion. Deaths from respiratory depression have been reportedin patients receiving midazolam and an opioid. In somecases, apnea may occur as long as 30 minutes afteradministration of the last dose of midazolam. In gen-eral, midazolam-induced respiratory depression isshort-lived and often responds to verbal stimulationand supplemental oxygen. Disinhibition reactions,manifested by hostility, rage, and aggression may occurwith the use of benzodiazepines.

Flumazenil (benzodiazepine antagonist). Fluma-zenil competitively antagonizes the central effects of ben-zodiazepines, reversing sedation, psychomotor impair-ment, memory loss, and respiratory depression. It is moreeffective in reversing the benzodiazepine-induced sedationand amnesia than the respiratory depression. The half-lifeof flumazenil after intravenous administration is 0.7 to1.3 hours, and the average duration of antagonism is 1hour. Because the effects of midazolam may persist 80minutes or longer, sedation may recur.

Andrews randomized 50 patients undergoing EGD undermidazolam sedation to receive either flumazenil or placebopost-procedure and 30 minutes later. Patients receivingflumazenil (0.5 mg) experienced greater improvement inmemory, psychomotor performance, and coordination at 5minutes post-procedure (P � .001). Re-evaluation 3.5 hourspost-procedure noted no difference in these same measuredparameters between the flumazenil-treated group and theplacebo-treated group. Bartelsman et al evaluated the use offlumazenil versus placebo in 69 patients sedated with mida-zolam for EGD. Flumazenil or placebo was administered 15seconds after completion of the endoscopic procedure. Meansedation scores returned to baseline within 5 minutes afterthe administration of flumazenil, and this effect persisted for60 minutes. This response was significantly different com-pared with placebo. No evidence of resedation was notedduring a 6-hour observation period in patients receivingflumazenil.

Caution should be exercised when administeringflumazenil to patients using chloral hydrate, carbamaz-

epine, high-dose tricyclic antidepressants, or chronic ben-

zodiazepines because it may induce seizures or withdrawalreactions.

The elective use of flumazenil after completion of en-doscopy has been demonstrated to reduce recovery time,although the practical benefits to the patient or the en-doscopy unit have not been proven.

Propofol. Propofol (2,6-diisopropofol) is a hyp-otic with minimal analgesic effect. At subhypnotic doses,ropofol produces sedation and amnesia. Propofol isighly lipid soluble and has an onset of action of 30 to 45econds. Its duration of effect is 4 to 8 minutes. Theharmacokinetic parameters of propofol are altered by aariety of factors including weight, sex, age and concom-tant disease. However, the presence of cirrhosis or renalailure does not significantly affect its pharmacokineticrofile. The coadministration of other central nervousystem medications such as opioids and barbiturates po-entiate the sedative effect of propofol.

The current formulation of propofol contains 1%ropofol, 10% soybean oil, 2.25% glycerol, and 1.2% puri-ed egg phosphatide. Propofol should therefore bevoided in persons with allergies to egg, soy, or sulfite.

The cardiovascular effects of propofol include decreasesn cardiac output, systemic vascular resistance, and arte-ial pressure. Pain on injection is reported in as many as0% of patients receiving an intravenous bolus of propo-ol. This occurs when small veins are chosen for the IVite. The use of lidocaine can minimize the discomfort.

There are only a few published studies that directly com-are combination propofol with standard sedation agents.apsatis studied propofol plus midazolam (mean doses 80nd 3 mg) versus midazolam and pethidine (mean doses 5nd 75 mg) in 120 patients undergoing colonoscopy. Pa-ients receiving propofol were more likely to report no dis-omfort during their procedure (84.3% vs 66%, P � .05) andecovered faster. No difference in the rate of cardiopulmo-ary complications was observed. Reiman randomized 79atients undergoing colonoscopy to receive sedation eitherith propofol plus midazolam (median doses 100 and 2 mg)r midazolam (median dose 9 mg) either alone or combinedith nalbuphine (median dose 20 mg). Patients in theropofol group were more likely to rate their procedure asomfortable (81 vs 47%, P � .02), and recovery time washorter (12 vs 93 minutes, P � .001). There was no differencen cardiorespiratory parameters between the 2 groups.

Other agents. Ketamine. Ketamine, unlike manyother drugs used for sedation, possesses both analgesic andsedative properties. It is further distinguished by its lack ofdepressant effect on the cardiovascular and respiratory sys-tems. Ketamine produces a trancelike cataleptic state thatimpairs sensory recognition of painful stimuli and memory.It also blocks opiate receptors in the brain and spinal cord,accounting for some of its analgesic effect.

Ketamine is highly lipid soluble with a rapid onset ofaction (�1 minute) and short duration of action (15-30minutes). Ketamine is easy to administer and, in contrast

to benzodiazepine/narcotic regimens, does not depress

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airway or cardiovascular reflexes even when administeredat doses 5 to 100 times greater than intended.

The use of ketamine for endoscopic sedation has beenstudied predominantly in the pediatric setting. In a ret-rospective review of children ranging in age from 1 monthto 20 years, a combination of ketamine (0.75-2.0 mg/kg)and midazolam (0.05-0.2 mg/kg) (N � 128) was com-pared with 2 alternative regimens, midazolam and meper-idine (1-2 mg/kg) (N � 192) and midazolam, meperidine,and ketamine (N � 82). Inadequate sedation was lessfrequent with ketamine/midazolam than either of theother sedation groups (3.1 vs 8.9% and 8.6%, P � .07).

omplications, predominantly hypoxemia, were signifi-antly more common with midazolam/meperidine thann either of the ketamine arms. A single patient in theetamine group (1/128, �1%) experienced transient hy-oxemia; otherwise, there were no serious adverse events.n adults, ketamine has been useful as an adjunct totandard sedation for difficult-to-sedate patients.

Ketamine produces a dose-dependent increase in heartate, blood pressure, and cardiac output, mediated throughtimulation of the sympathetic nervous system. Emergenceeaction, manifested by floating sensations, vivid dreams,allucinations, and delirium, has been reported in 10% to0% of adults. The use of midazolam in combination withetamine is reported to minimize this reaction.

Nitrous oxide. Nitrous oxide is an inhalationalagent coadministered with oxygen. Nitrous oxide is arelatively strong analgesic and weak hypnotic that may beused alone or in combination with other agents. Afterinhalation, the gas is quickly cleared and excreted un-changed by the lungs. The benefits of nitrous oxide in-clude rapid onset, rapid recovery, and an excellent safetyprofile.

Saunders performed a randomized, placebo-controlledtrial of patient-controlled nitrous oxide versus intrave-nous pethidine and midazolam (mean doses 50 and 2.5mg) in patients undergoing routine colonoscopy. Proce-dure-related discomfort was comparable between studygroups. Patients receiving intravenous sedation experi-enced more prolonged sedation and slower recovery thanthe nitrous oxide group (60 vs 32 minutes, P � .001).Hypotension and oxygen desaturation were more com-mon with intravenous sedation than with nitrous oxide,whereas many in the nitrous oxide group experiencedheadache.

Maslekar recently reported the results of a randomized,controlled study that compared nitrous oxide with intra-venous fentanyl and midazolam. One hundred twentypatients undergoing colonoscopy were randomized. Pa-tients in the nitrous oxide arm all completed colonoscopywithout supplemental medications and scored better withrespect to overall satisfaction and the assessment of pain.The time to discharge was significantly shorter in thenitrous oxide arm (26 vs 44 minutes; P � .0004).

The major risk of nitrous oxide is hypoxia, which is

avoided by coadministration with 30% to 50% oxygen.

Hypertension, arrhythmias, nausea, vomiting, and head-ache have also been reported with nitrous oxide.

Dexmedetomidine. Unlike other sedative agents,atients sedated with dexmedetomidine return to their base-

ine level of consciousness when stimulated. Furthermore,exmedetomidine produces less respiratory depression thanther sedative agents. The pharmacologic effects of dexme-etomidine can be reversed by the �2-receptor antagonisttipamezole. These beneficial properties make dexmedeto-idine an attractive sedation agent for short procedures.The usual dose of dexmedetomidine for procedure se-

ation is 1 �g/kg, followed by an infusion of 0.2 �g/kg/h.Its onset of action is less than 5 minutes, and the peakeffect occurs within 15 minutes. Jalowiecki randomizedpatients undergoing colonoscopy to dexmedetomidine (1�g/kg followed by 0.2 �g/kg/h) or meperidine (1 mg/kg)

nd midazolam (0.05 mg/kg). Supplemental fentanyl (0.1-.2 mg) was available on demand. Forty-seven percent ofatients receiving dexmedetomidine required supplemen-al fentanyl to achieve satisfactory analgesia. Hypotension4/19, 21%), bradycardia (2/19, 10%), and vertigo (5/19,6%) were reported in the group receiving dexmedetomi-ine. Recovery time was longest (85 minutes) in patientseceiving dexmedetomidine.

Diphenhydramine. The usual dose of intravenousdiphenhydramine as an adjunct for endoscopic sedationis 25 to 50 mg. Diphenhydramine is quickly distributedthroughout the body, including the central nervous sys-tem. Its onset of action is several minutes and duration ofeffect is up to 4 to 6 hours. Its hypnotic effect is increasedwhen given in combination with alcohol or other centralnervous system depressants such as benzodiazepines andopioid narcotics. Diphenhydramine has a modest stimu-latory effect on ventilation and has been reported tocounteract opioid-induced hypoventilation.

Diphenhydramine was assessed as an adjunct to meper-idine and midazolam during colonoscopy in a random-ized, double-blind trial. Two hundred seventy patientsreceived intravenously either diphenhydramine 50 mg orplacebo 3 minutes before initiating sedation. Patientscores for overall sedation were better in the group receiv-ing diphenhydramine (9.4 vs 9.04, P � .017). Further, the

iphenhydramine group required less meperidine (89.7 vs00 mg, P � .003) and midazolam (3.4 vs 4.0 mg, P �

001). Procedure, recovery, and discharge times were com-arable between both groups.The adverse effects of diphenhydramine include hypo-

ension, dizziness, blurred vision, dry mouth, epigasticiscomfort, urinary retention, and wheezing.

Promethazine. Promethazine is a phenothiazinethat possesses antihistamine, sedative, antiemetic, andanticholinergic effects. Promethazine has also been inves-tigated as an adjunct for sedation during minor surgicaland endoscopic procedures.

The clinical effects of promethazine are evident within5 minutes of intravenous administration. Its duration ofaction is 4 to 6 hours, and the plasma half-life is 9 to 16

hours. The usual dose of promethazine is 12.5 to 25 mg

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intravenously, infused slowly (�25 mg/min) to minimizethe risk of hypotension. A total dose of 25 to 50 mg maybe used as an adjuvant to narcotics and benzodiazepines.The use of promethazine may require a reduction in thedose of standard sedation agents.

The adverse effects of promethazine include hypoten-sion, respiratory depression, neuroleptic malignant syn-drome, and extrapyramidal effects ranging from restless-ness to oculogyric crises. Adverse reactions includingburning, pain, thrombophlebitis, tissue necrosis, and gan-grene can occur with inadvertent perivascular extravasa-tion, unintentional intra-arterial injection, and intraneu-ronal or perineuronal infiltration.

Droperidol. Droperidol is a neuroleptic (tranquil-izer) agent. It can be given intramuscularly or intrave-nously. Droperidol is used as an adjunct to standardsedation for complex endoscopic procedures or difficult-to-sedate patients such as alcoholics and long-term drugabusers. Droperidol’s onset of action is 3 to 10 minutes,and its duration of effect is 2 to 4 hours. The usual doseof droperidol for endoscopic sedation is 1.25 to 2.5 mgintravenously, although higher doses have been used.

LeBrun reported the first large series using droperidolfor endoscopic sedation. Patients achieved adequate seda-tion for upper endoscopy, although 24% experienced tran-sient hypotension. No major complications were reported.Sixty difficult-to-sedate patients undergoing EGD weresedated with either fentanyl/diazepam or fentanyl/dro-peridol. Sedation with fentanyl/droperidol was assessed tobe better than the diazepam/fentanyl combination. Wil-cox used droperidol as an adjunct to standard sedation in764 patients undergoing 1102 endoscopic procedures.The indications for droperidol included active alcoholwithdrawal, patients who were difficult-to-sedate during aprevious endoscopic examination, and long-term narcoticand/or intravenous drug users. The total dose of droperi-dol ranged from 1.25 to 5.0 mg intravenously. Hypoten-sion was the most common complication. No patientexperienced respiratory depression requiring ventilatorysupport.

Hypotension, prolongation of the QTc interval, andxtrapyramidal signs are the major side effects of droperi-ol. In 2001, the U.S. Food and Drug Administrationevised their product labeling that warned of the po-ential for sudden cardiac death at high doses of dro-eridol (�25 mg) in psychiatric patients. A “black-box”arning was added to the product label, indicating that

ven low-dose droperidol should be used only whenrst-line drugs are unsuccessful. Droperidol use is con-raindicated in patients with a prolonged QTc interval�440 ms in males, �450 ms in females) and should bevoided in patients at increased risk of the developmentf QT interval prolongation (history of congestive heartailure, bradycardia, diuretic use, cardiac hypertrophy,ypokalemia, hypomagnesemia, 65 years of age andlder, and alcohol abuse).

Fospropofol. Fospropofol disodium, a water-solu-

le prodrug of propofol, is designed to modify the pharma-

okinetic properties of propofol emulsion to enhance itsffectiveness and safety profile during procedure sedation. Its a sedative/hypnotic. Fospropofol is rapidly hydrolyzed bylkaline phosphatases, releasing propofol as an active me-abolite along with formaldehyde and phosphate. After bo-us administration of fospropofol, the plasma concentrationf liberated propofol has a slower upward slope, lower peak,nd prolonged plateau phase compared with an equipotentose of propofol emulsion.

A phase II, double-blind, multicenter dose-responsetudy randomized patients undergoing elective colonos-opy to 1 of 4 weight-based doses of fospropofol diso-ium (2, 5, 6.5, or 8 mg/kg) or midazolam (0.02 mg/kg).ll patients received a pretreatment dose of fentanyl (50

�g). Fospropofol 6.5 mg/kg produced moderate sedationthroughout most of the examination (84.6%), and only 1of 26 patients in this dose group experienced transientdeep sedation. More than 90% of patients and physiciansindicated their satisfaction with this level of sedation.The time from completion of procedure to ready fordischarge was 9.1 minutes. The most common adverseevents were burning sensation (23.8%), paresthesias(8.9%), and pruritus (7.9%). To date, there are no re-ported trials comparing fospropofol with propofol forendoscopic sedation.

Pharyngeal anesthetic agents. Topical anestheticagents such as benzocaine, lidocaine, and tetracaine havebeen used as an adjunct to moderate sedation to facilitateupper endoscopic procedures. From a meta-analysis of 5randomized, controlled studies, subjects who rated theirdiscomfort as none/minimal were more likely to havereceived pharyngeal anesthesia (odds ratio 1.88; 95% CI,1.13-3.12). Endoscopists were more likely to rate the pro-cedure as “not difficult” if the subjects received pharyn-geal anesthesia (odds ratio 2.60; 95% CI, 1.63-4.17). How-ever, topical anesthetic agents have been associatedwith a potentially life-threatening adverse event knownas methemoglobinemia. Diagnosis is by multiple wave-length co-oximetry. The condition cannot be detectedby standard pulse oximetry or blood gases. A high levelof clinical suspicion manifested by the presence ofcyanosis despite adequate supplemental oxygen deliveryshould alert the endoscopist to the possibility of met-hemoglobinemia. Treatment is with intravenous meth-ylene blue 1 to 2 mg/kg over 3 to 5 minutes, followedby a 15- to 30-mL fluid flush. If there is no improve-ment, an additional 1-mg/kg dose of methylene bluecan be administered in 30 to 60 minutes. Failure toimprove at this point may be because of coexistentglucose-6-phosphate dehydrogenase or reduced nico-tinamide adenine dinucleotide phosphate oxidase met-hemoglobin reductase deficiency.

Sponsoring Societies

American Association for the Study of Liver Diseases

American College of Gastroenterology

American Gastroenterological Association Institute

July 2012 AGA e41

American Society for Gastrointestinal Endoscopy

Society for Gastroenterology Nurses and Associates

Contributors

John J. Vargo, MD, MPH, Committee Chair

Cleveland Clinic Lerner College of MedicineChairman, Department of Gastroenterology and HepatologyDigestive Disease InstituteCleveland ClinicCleveland, Ohio, USA

Mark H. DeLegge, MDDigestive Disease CenterMedical University of South CarolinaCharleston, South Carolina, USA

Andrew D. Feld, MD, JDGroup Health CooperativeDivision of GastroenterologyUniversity of WashingtonSeattle, Washington, USA

Patrick D. Gerstenberger, MD

Digestive Health Associates, PCDurango, Colorado, USA

Paul Y. Kwo, MDMedical Director, Liver TransplantationGastroenterology/Hepatology DivisionIndiana University School of MedicineIndianapolis, Indiana, USA

Jenifer R. Lightdale, MD, MPHChildren’s Hospital BostonHarvard Medical SchoolBoston, Massachusetts, USA

Susan Nuccio, RN, MSN, ACN-BC, CGRNAurora St. Luke’s Medical CenterMilwaukee, Wisconsin, USA

Douglas K. Rex, MDIndiana School of MedicineDirector of EndoscopyIndiana University HospitalIndianapolis, Indiana, USA

Lawrence R. Schiller, MDDigestive Health Associates of Texas

Baylor University Medical CenterDallas, Texas, USA

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