CO-AUTHORS Prof & HOD Dr.I.Chandrasekaran M.D.,D.A., Prof Dr.S.P.Meenakshisundaram M.D.,D.A.,
description
Transcript of CO-AUTHORS Prof & HOD Dr.I.Chandrasekaran M.D.,D.A., Prof Dr.S.P.Meenakshisundaram M.D.,D.A.,
CO-AUTHORSProf & HOD Dr.I.Chandrasekaran M.D.,D.A.,Prof Dr.S.P.Meenakshisundaram M.D.,D.A.,
Asst. Prof Dr.D.S.Sudhakar M.D.,DNB.,
AUTHOR : G.N.Jeevanandam IIyr M.D. PGINSTITUTE OF ANAESTHESIOLOGY , Madurai Medical College
Post Operative Nausea & Vomiting
Second most common complaints reported
Unpleasant experience often rated worse than
postoperative pain
Medical risks : Aspiration of gastric contents,
Suture dehiscence,
Esophageal
rupture,
Subcutaneous emphysema, Pneumothorax
HR & BP elevation(risk for MI & dysrhythmias )
Bradycardia and hypotension.
RISK FACTORS APFEL Simplified risk scoring for adults
PALONOSETRON•Potent and selective 5-HT3
antagonist
•Plasma elimination T½ ~ 40 h
•Metabolized primarily by
liver.
•Age, hepatic dysfunction or
mild-to-moderate renal
impairment have no clinically
significant effect on the
pharmacokinetics
MECHANISM OF ACTIONAntagonism of 5HT3
receptors
Also has an allosteric binding
site
Causes receptor
interanalisation and
prolonged inhibition
USESPrevention of postoperative nausea and vomiting
Prevention of acute and delayed nausea and vomiting
associated chemotherapy.
Dosage and Administration
Postoperative Nausea and Vomiting
IV 0.075 mg before the induction of anesthesia.
Chemotherapy-Induced Nausea and Vomiting
IV 0.25 mg administered 30 min before the start of
chemotherapy.
PO 0.5 mg administered 1 h prior to the start of chemotherapy.
SIDE EFFECTSCOMMON Headache
Constipation
OTHERS
• Cardiovascular :ECG QT prolongation, bradycardia,
hypotension, tachycardia.
• CNS : Headache, anxiety, dizziness,
weakness.
• Gastro Intestinal: Constipation, diarrhea.
• Genitourinary: Urinary retention.
• Hepatic: Increased ALT, increased AST.
AIMTo evaluate the efficacy of
Palonosetron versus placebo for
prevention of Postoperative
Nausea and Vomiting
DESIGNRandomized double blind control study
Female patients undergoing laproscopic surgery under GA
Inclusion criteria
Age 18 - 60 yrs
ASA I - II
Non - Smokers
Exclusion criteria
Patients received antiemetics 24 hrs prior to surgery
Patients received / undergoing chemotherapy or
radiotherapy
Pre existing heart blocks , bradycardia, QT prolongation,
Duration of procedure <1 hr
METHODSEthical committee approval
Informed consent
Randomised allocation into 2 groups
Group Pn : Inj.Palonosetron 0.o75mg I.V
Group Po : Placebo ( Normal Saline 1.5ml ) I.V
All patients premedicated with Inj.Midazolam 0.05mg/kg &
Inj.Glyco 0.2mg im 45 min before induction
I.V lines will be secured
Preinduction monitors NIBP, Pulse oximetry, ECG, connected
Just prior to Induction of anesthesia patients will receive the
allocated drug or equal volume of normal saline I.V
Induced with Inj.Thio 5mg/kg ,Inj.Fentanyl 2mics/kg ,Inj.Suxa
2mg/kg
Maintainence with intermittent titrated dose of Inj.Atracurium ,
Inj.Fentanyl and N2O : O2 ( 60 : 40 )
Reversal with Inj.Neostigmine 40mics/kg & Inj.Glyco 10mics/kg
and extubation
DATA COLLECTIONEMETIC episodes (vomiting and retching)
Intensity of Nausea (VAS scoring for nausea)
both at 2 ,6 , 24, 48, 72 hrs with respect to their
occurrence over the previous observation period
Rescue therapy Inj.Metoclopromide 10mg I.V when
VAS > 4 / emetic episodes
Complete response (defined as no emetic episodes
and no rescue medication) will be noted for the time
interval of 0 – 24 hrs & 24 – 72 hrs
Patients Age ,Weight,BMI
Risk factors for PONV (H/O PONV , H/O motion
sickness )
Duration of surgery
Total intra operative opioid (fentanyl) dose
Post operative opioid use will be noted (proposed post
operative pain relief : Inj.Tramadol 100mg I.M)
Side effects like headache ,constipation and other
adverse events will be noted
PHYSIOLOGICAL PARAMETERSVARIAB
LE
GROUP Pn
(n = 30)
GROUP
Po
(n = 30)
“p”
Age in
years
27.3 + 4.4 26.3 +
3.9
0.380
8
Weight
(in
kgs)
53.7 + 5.4 54.8 +
3.5
0.542
8
Height
( in
cms)
151.2 +
3.1
151.7 +
2.7
0.479
6
BMI 23.4 + 2 23.8 +
1.3
0.428
9
ASA RISK
ASA GROUP Pn GROUP Po
n % n %
I 26 86.7 27 90
II 4 13.3 3 10
‘p’ 0.691
DURATION OF PROCEDURE
DUR OF
PROC
GROUP Pn GROUP Po
Range 80 - 140 80 – 135
Mean 107.8 105.2
S.D. 15.2 12
‘p’ 0.4898
TOTAL INTEROPERATIVE OPIOID USED
TOT. OPIOD
USED
GROUP
Pn
GROUP
Po
Range 130 - 210 140 –
200
Mean 167 163.3
S.D. 17.4 17.9
‘p’ 0.3156
APFEL SCORE
APFEL
SCORE
GROUP Pn GROUP Po
No. % No. %
3 25 83.3 27 90
4 5 16.7 3 10
Total 30 100 30 100
RangeMeanS.D.
3 – 43.170.38
3 – 43.1
0.31
‘p’ 0.4513
INTENSITY OF NAUSEA ( VAS )
INT OF
NAUSEA
GROUP
Pn
GROUP
Po
“p”
0 – 2 hrs 2.43 +
2.21
4.43+
1.65
0.000
8
2 – 6 hrs 1.53 +
1.63
3.07 +
1.31
0.000
4
6 – 24
hrs
1.3 +
1.66
2.3 +
1.52
0.003
4
24 – 72
hrs
0.9 +
1.49
2.07 +
1.51
0.001
3
EMETIC EPISODES 0 – 24 HR Interval
EMETIC
EPISOD
ES
GROUP Pn GROUP Po
n % n %
YES10 33.3 22 73.3
NO20 66.7 8 26.7
“p” 0.0044
EMETIC EPISODES 24 – 72 HR Interval
EMETIC
EPISOD
ES
GROUP Pn GROUP Po
n % n %
YES8 26.7 10 33.3
NO22 73.3 20 66.7
“p” 0.7763
COMPLETE REMISSION 0 – 24 HR Interval
COMPLE
TE
REMISSI
ON
GROUP Pn GROUP Po
n % n %
YES20 66.7 8 26.
7
NO10 33.3 22 73.
3
“p” 0.0044
COMPLETE REMISSION 24 - 72HR Interval
COMPLE
TE
REMISSI
ON
GROUP Pn GROUP Po
n % n %
YES22 73.3 20 70
NO8 26.7 10 30
“p” 0.7763
SUMMARYRandomised controlled study
Two groups, 30 patients in each
Female patients ,non-smokers ,undergoing
laproscopy of more than one hour duration
receiving opioids for postoperative pain relief
Inj.Palonosetron 0.075 mg Vs Placebo
Data collected regarding the incidence of emetic
episodes & the intensity of nausea by VAS scoring
Statistical analysis revealed that both groups were
comparable with regared to their demography
OBSERVATIONS Patients receiving Palonosetron compared to
control group have
Significant reduction in incidence of Emetic
episodes and greater Complete remission in
the first 24 hrs following surgery
Significantly low VAS scores for nausea over
the period of 72 hrs
No significant difference in Emetic episodes and
complete remission over 24-72hr period
Treatment effect of PALONOSETRON in this trial
was most pronounced during the first 24 h
No side effects
CONCLUSIONPALONOSETRON 0.075mg was
statistically superior to placebo for all
end-points during the first 24 h, including
Complete remisison ,emetic episode
incidence & intensity of nausea with no
adverse effects
In the 24-72 hr it has the advantage of
having good control of intensity of nausea
REFERENCESA Randomized, Double-Blind Study to Evaluate the
Efficacy and Safety of Three Different Doses of
Palonosetron Versus Placebo in Preventing Postoperative
Nausea and Vomiting Over a 72-Hour Period(Anesth Analg
2008;107:439 –44)
A Randomized, Double-Blind Study to Evaluate the
Efficacy and Safety of Three Different Doses of
Palonosetron Versus Placebo for Preventing Postoperative
Nausea and Vomiting(Anesth Analg 2008;107:445–51)
OBSERVATIONS ‘ p ‘ value calculated for
age, weight, height,
BMI, ASA
status&Apfel scores
‘ p ‘ value calculated for the
duration of procedure &
total dose of fentanyl
used
No adverse effects were observed in both groups
>0.05 insignificant
>0.05 insignificant
OBSERVATIONS contd‘p ‘ value for VAS scoring of nausea in the interval
0 – 2 hr ( p=0.0008) 2 – 6 hr (p=0.0004)
6 -24 hr (p=0.0034) 24 – 72
hr(p=0.0013)
0 – 24 hr time interval, ‘ p ‘ value for
emetic episode incidence (p=0.0044)
& complete remission (p=0.0044)
24-72 hr time interval interval ‘ p ‘ value for
emetic episode incidence (p=0.7763)
& complete remission
(p=0.7782)
< 0.05 significant
> 0.05 insignificant
< 0.05 significant