SYNOPSIS

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

“COMPARISON OF HAEMODYNAMIC RESPONSE TO

ENDOTRACHEAL INTUBATION IN HYPERTENSIVE PATIENTS

WITH I.V. ESMOLOL V/S I.V. MAGNESIUM SULPHATE”

Name of the candidate : Dr. RENITA MARINA PINTO.

Guide : Dr. SRIKANTU J.

Course and Subject : M.D (Anaesthesiology)

Department of Anaesthesiology,

Father Muller Medical College,

Kankanady, Mangalore – 575002.

1

August – 2007

Rajiv Gandhi University Of Health Sciences, Karnataka,

Bangalore

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

1. Name of the Candidate

and Address

[in block letters]

DR. RENITA MARINA PINTO

POST GRADUATE RESIDENT

DEPARTMENT OF ANAESTHESIOLOGY

FR. MULLER MEDICAL COLLEGE

MANAGLORE – 575002

2. Name of the Institution FATHER MULLER MEDICAL COLLEGE

KANKANADY

MANGALORE – 575002.

3. Course of study and

subject

M.D. IN ANAESTHESIOLOGY

4. Date of admission to

Course16 t h APRIL 2007

5. TITLE OF THE TOPIC:

“COMPARISON OF HAEMODYNAMIC RESPONSE TO

ENDOTRACHEAL INTUBATION IN HYPERTENSIVE

PATIENTS WITH I.V. ESMOLOL V/S I.V. MAGNESIUM

2

SULPHATE”

6.

BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY:

Reflex sympathetic discharge due to laryngoscopy and

intubation causes transient self limiting increase in heart-rate, blood

pressure and intra–cranial pressure. These changes are exaggerated

even in well controlled hypertensive patients. 1 This hemodynamic

response can be detrimental in patients with ischemic heart disease

and intra–cranial aneurysms. 1 Various pharmacological measures

using adrenoreceptor blockers, calcium channel blockers, opioids and

vasodilators have been employed to attenuate responses, which

indicate lack of an ideal drug for this purpose. 1

Not many studies have been done on pressor response

blunting in hypertensive patients. Esmolol, cardio–selective

β-blocker due to its rapid onset of action, peak effect within minutes

and short elimination half life prompted us to study its effect on

short l ived pressor response. Previous authors employed variable

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doses (1.5 – 4 mg/kg body wt) 2 , 3 , 4 at variable pretreatment time (just

before intubation – 2minutes pre–intubation) 2 , 3 , 4 and conclusions

were conflicting. Catecholamine release inhibit ion and coronary

arterial dilatation by Magnesium Sulphate 5 prompted us to study the

effect of Magnesium Sulphate on pressor response. Few studies done

by other authors with variables doses (40 – 50 mg/kg) 4 , 5 and variable

pre- treatment time (2 – 4 minutes pre–intubation) 4 , 5 of Magnesium

Sulphate have yielded conflicting conclusions. No similar study has

been done in our insti tution. Hence this study.

6.2 REVIEW OF LITERATURE:

S.Sharma 2 studied the effects of just before intubation placebo,

Esmolol 100mg or 200mg on 45 hypertensive patients. They

concluded that Esmolol 100mg bolus just before intubation

attenuated the pressor response to intubation with, no side effects.

Esmolol 200mg resulted in haemodynamic variables below basal

readings for most of post–intubation period.

Samaha T 3 studied the effects of 2 minutes pre-intubation i .v.

Esmolol 1.5mg/kg or Lidocaine 1.5mg/kg on 22 ASA Physical status

I or ASA Physical status II patients (majority were hypertensives)

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undergoing neurosurgery. They concluded that 2 minutes pre–

intubation Esmolol or Lidocaine i.v. bolus of 1.5mg/kg does not

completely prevent the increase in mean arterial pressure and intra –

cranial pressure. There were no side effects.

A.A. Van Den Berg 4 studied 100 elderly patients suffering from

either diabetes, hypertension, ischemic heart disease or combination

undergoing cataract extraction. They studied the effects of 2 minutes

pre–induction i .v. Magnesium Sulphate 40mg/kg, Esmolol 4.0mg/kg,

Lignocaine 1.5mg/kg or Glyceryl Trinitrate 7.5g/kg on pressor

response to laryngoscopy and tracheal intubation. They concluded

that 2 minutes pre-intubation Magnesium Sulphate and Lignocaine

did not prevent responses to laryngoscopy and tracheal intubation

and were associated with rises in rate pressure product. Esmolol

attenuated the response with lesser rate pressure product.

GD Puri 5 studied the effects of 4 minutes pre-induction i.v.

Magnesium Sulphate 50mg/kg or Lidocaine 1mg/kg on pressor

response to laryngoscopy and tracheal intubation in 36 patients

scheduled for elective coronary artery bypass grafting. They

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concluded that 4 minutes pre-intubation Magnesium Sulphate caused

lesser haemodynamic and ST segment changes compared with

Lidocaine at the time of endotracheal intubation. Magnesium

Sulphate attenuated the pressor response with out any side – effects.

Cheng M H 6 studied the effects of 2 minutes

pre-intubation Esmolol 2mg/kg, Fentanyl 2g/kg and their

combination on hemodynamic and catecholamine response to tracheal

intubation in 60 hypertensive patients. They concluded that

2 minutes pre-intubation Esmolol or Fentanyl are effective in

attenuating the haemodynamic and catecholamine response to

tracheal intubation with no side effects. But the combination was

more effective than either drug alone.

Kamran Montazeri 7 studied the effects of 2 minutes pre induction

i.v. Magnesium Sulphate 10, 20, 30, 40, 50 mg/kg and Lidocaine

1.5mg/kg on pressor response to laryngoscopy and tracheal

intubation in 120 patients undergoing elective surgery. They

concluded that 2 minutes pre-intubation treatment with different

doses of Magnesium Sulphate have a safe decreasing effect on

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cardiovascular responses to intubation. No side effects were

recorded.

Louizos AA 8 studied the effects of 2 minutes pre-intubation

placebo, Esmolol 1mg/kg or 2mg/kg on 165 patients {ASA Physical

status I – ASA Physical status III (majority were hypertensives}.

They concluded that 2 minutes pre-intubation i.v Esmolol 2mg/kg

attenuated the haemodynamic response to laryngoscopy and tracheal

intubation with no side effects.

6.3 OBJECTIVES OF THE STUDY:

a) To evaluate the change in Heart rate, Blood pressure and

Rate pressure product to laryngoscopy and intubation in

hypertensive patients.

b) To study and compare the effect on Heart rate, Blood

Pressure and Rate pressure product of i.v. bolus

Esmolol 2mg/kg and i.v. Magnesium Sulphate 50mg/kg.

c) Effectiveness of timing of the study drug administration.

d) To evaluate the side effects and safety of study drugs.

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7.

MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

Ninety well controlled hypertensive inpatients of Fr. Muller

hospital for elective procedure under general anaesthesia will be taken

up for our study.

7.2 METHOD OF COLLECTION OF DATA:

Inclusion criteria:

- ASA physical status II adult

- Well controlled hypertensive patients on regular

antihypertensive medications with blood pressure < 140/90

mm of Hg 9 for atleast 1 week.

1. Patients of the both sexes 2. Age: 40 – 70 years 3. Weight: 40 – 70 kg.

Exclusion criteria:

- ASA III and above

- Pregnancy induced hypertension

- Bronchial asthma

- Congestive cardiac failure, LVEF < 40%

- Pre-induction heart rate < 60 bpm

- Heart block – 2 0 and 3 0

Design: Prospective randomized placebo controlled double blind study

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of 90 treated hypertensive patients undergoing general anaesthesia.

Brief description of plan of study:

Following approval of our insti tutional ethics committee

informed written consent obtained from patients included in our study.

During preanaesthetic evaluation adequacy of Blood Pressure control,

Airway and optimization of other systemic il lness if any were

assessed. Haematological investigations, ECG and Chest x–ray were

evaluated. Tab Diazepam 0.1mg/kg given H.S. and patient starved

overnight. All patients received 2 hours pre-operatively morning dose

of anti-hypertensive (except ACE inhibitors) 1 and Pethidine 1mg/kg

i.m. as premedication. For the entire study one anaesthetist loaded the

placebo or study drugs (diluted to the same volume) in coded syringes.

Another anaesthetist who was blinded to the study drug administered

the study drug and performed the endotracheal intubation to all the

patients and recorded the parameters.

Randomization of the patients into 3 groups vide-infra is done by

double blind lottery method.

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Placebo (control): saline – 30 patients

Esmolol group : 2mg/kg i.v. bolus – 30 patients

Magnesium Sulphate group : 50mg/kg i.v. bolus – 30 patients

Non invasive Blood pressure and ECG lead II were patients monitors.

Pre-induction (0 hour) Heart rate and Pressures – systolic, diastolic

and mean were recorded. Coded placebo/study drugs injected i.v. over

30 seconds. Anaesthesia induced with 5mg/kg Thiopentone Sodium

followed by 2mg/kg Succinylcholine. 2 minutes after administration of

placebo/study drugs laryngoscopy (duration<15 seconds) and single

attempt oral intubation performed. Heart rate and pressure – systolic,

diastolic and mean recorded soon after intubation. Difference between

soon after intubation reading and 0 hours reading will be taken as

pressor response to intubation. Subsequently Anaesthesia maintained

with Oxygen-33%, Nitrous oxide-67%, 0.5% Halothane (for better tube

tolerance and preventing Awareness) and Vecuronium with Controlled

ventilation by a Bains circuit throughout the study period and ti ll the

end of surgery. Readings Heart rate and Pressure – systolic, diastolic

and mean were taken at 1, 3, 5, 7 and 9 minutes post-intubation. Rate

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pressure product derived. No position change, patient handling and

surgical incision allowed ti ll study period was over. ECG rhythm

changes and side effects of drugs noted. After the study period

Fentanyl 1g/kg i.v. bolus given for intra–operative analgesia. Heart

rate and Blood Pressure recorded every 10 minutes ti ll the end of

surgery. At the end of the procedure patient reversed with Neostigmine

0.05mg/kg body wt & Atropine 0.02mg/kg body wt.

Statistical test: Anova test to interpret haemodynamic variables,

chi-square to interpret categoric variables and unpaired t-test for

chain scores were used.

7.3 Does the study require any investigations or interventions to be

conducted on patients or other humans or animals? If so, please

describe briefly.

No

7.4 Has ethical clearance been obtained from your institution in

case of 7.3

Yes

8. LIST OF REFERENCES:

1. Robert K. Stoelting and Stephen F. Dierdorf: Anesthesia and

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Co-Existing Disease -4 t h edit ion, 2002.

2. S. Sharma, S. Mitra, VK Grover and R Kalra: Esmolol blunts the

haemodynamic responses to tracheal intubation in treated

hypertensive patients. Can J Anaesth 1996; (43): 778- 782.

3. Samaha T, Ravussin P, Claquin C and Ecoffey C: Prevention of

increase of blood pressure and intracranial pressure during

endotracheal intubation in neurosurgery: Esmolol versus

Lidocaine. Ann Fr Anesth Reanim 1996; 15(1): 36-40.

4. A.A. Van Den Berg, D. Savva and N.M. Honjol: Attenuation of

the haemodynamic responses to noxious stimuli in patients

undergoing cataract surgery. A comparison of Magnesium

Sulphate, Esmolol, Lignocaine, Nitroglycerine and placebo given

i.v. with induction of anaesthesia. EJA 1997; 14: 134-147.

5. GD Puri, KS Marudhachalam, P Chari and RK Suri: The effect

of Magnesium Sulphate on hemodynamics and its efficacy in

attenuating the responses to endotracheal intubation in patients

with coronary artery disease. Anaesthesia and analgesia 1998; vol

87: 808-811.

6. Cheng MH and Yao YM: Effects of Esmolol and Fentanyl on the

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haemodynamic and catecholamine response to tracheal intubation

in hypertensive patients. Zhongguo Wei Zhong Bing Ji Jui Yi

Xue. 2003 Jul; 15 (7): 435-7.

7. Kamran Montazeri and M Falah: Dose-response study:

Magnesium Sulphate in cardiovascular responses after

laryngoscopy and endotracheal intubation. Canadian

Anaesthesiologists Society- Monday June 20, 2005; 1230-1400.

8. Louizos AA, Hadzilla SJ, Davills DI, Samanta EG and Georgiou

LG: Administration of Esmolol in microlaryngeal surgery for

blunting the hemodynamic response during laryngoscopy and

tracheal intubation in cigarette smokers. Ann Otol Rhinol

Laryngol 2007 Feb; 116(2): 107-11.

9. E. Braunwald, A.S. Fauci, D.L. Kasper, S.L. Hauser, D.L. Longo

and J.L. Jameson: Harrisons – Principles of internal medicine 15 t h

edition, 2001; vol-1 chapter 246 pg 1426.

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PROFORMA

Name: Age: Sex: Weight:

I.P.No: Study Group:

PAE:

Lab Data: RBS: S. Urea: S. Creatinine:

Chest X – Ray: ECG:

ASA Grade:

Pre- Medication:

Larynoscopy duration:

HR SBP DBP MAP RPP

Just before induction “0” hour

Soon after intubation

1 min post intubation

3 min post intubation

5 min post intubation

7 min post intubation

9 min post intubation

Response to Intubation = Soon after intubation reading – ‘0’ hour reading

ECG Changes:

Side effects : IV Fluids:

Intra OP. BP every 10 mins:

10 20

SBP

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DBP

Duration of surgery:

Reversal: Neostigmine + Atropine

Post Operative: Pulse: BP:

Recovery:

9. Signature of the candidate

10. Remarks of the guide

11. Name and Designation of (in block letters)11.1 Guide

DR.SRIKANTU J.ASSOCIATE PROFESSOR DEPARTMENT OF ANAESTHESIOLOGY FATHER MULLER MEDICAL COLLEGE KANKANADY, MANGALORE-2

11.2 Signature

11.3 Co-Guide

11.4 Signature

11.5 Head of the Department

DR.SUDHIR K.HEGDE PROFESSOR & H.O.DDEPARTMENT OF ANAESTHESIOLOGY FATHER MULLER MEDICAL COLLEGE KANKANADY, MANGALORE-2

11.6 Signature

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12. 12. 1 Remarks of the Chairman and Principal

12.2 Signature

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.: