EVALUATION OF EFFICACY AND SAFETY OF THREE DIFFFERENT DOSES OF
PALONOSETRON VERSUS PLACEBO FOR PREVENTION OF POSTOPERATIVE NAUSEA
AND VOMITTING
EVALUATION OF EFFICACY OF PALONOSETRON VERSUS PLACEBO FOR
PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITINGCO-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 1Post Operative Nausea
& VomitingSecond most common complaints reportedUnpleasant
experience often rated worse than postoperative painMedical risks :
Aspiration of gastric contents, Suture dehiscence, Esophageal
rupture, Subcutaneous emphysema, Pneumothorax HR & BP
elevation(risk for MI & dysrhythmias ) Bradycardia and
hypotension. 2RISK FACTORS APFEL Simplified risk scoring for
adults
3PALONOSETRONPotent and selective 5-HT3 antagonistPlasma
elimination T ~ 40 hMetabolized primarily by liver.Age, hepatic
dysfunction or mild-to-moderate renal impairment have no clinically
significant effect on the pharmacokinetics
4MECHANISM OF ACTIONAntagonism of 5HT3 receptorsAlso has an
allosteric binding siteCauses receptor interanalisation and
prolonged inhibition
5 USESPrevention of postoperative nausea and vomitingPrevention
of acute and delayed nausea and vomiting associated
chemotherapy.Dosage and AdministrationPostoperative Nausea and
VomitingIV 0.075 mg before the induction of
anesthesia.Chemotherapy-Induced Nausea and VomitingIV 0.25 mg
administered 30 min before the start of chemotherapy.PO 0.5 mg
administered 1 h prior to the start of chemotherapy.6SIDE
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.
7AIMTo evaluate the efficacy of Palonosetron versus placebo for
prevention of Postoperative Nausea and Vomiting8DESIGNRandomized
double blind control studyFemale patients undergoing laproscopic
surgery under GA Inclusion criteriaAge 18 - 60 yrsASA I - IINon -
SmokersExclusion criteriaPatients received antiemetics 24 hrs prior
to surgeryPatients received / undergoing chemotherapy or
radiotherapy Pre existing heart blocks , bradycardia, QT
prolongation,Duration of procedure 4 / emetic episodesComplete
response (defined as no emetic episodes and no rescue medication)
will be noted for the time interval of 0 24 hrs & 24 72
hrs12Patients Age ,Weight,BMIRisk factors for PONV (H/O PONV , H/O
motion sickness )Duration of surgeryTotal intra operative opioid
(fentanyl) dosePost 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
13ANALYSIS OF COLLECTED DATAPhysiological parametersVARIABLEGROUP
Pn(n = 30)GROUP Po(n = 30)pAge in years27.3 + 4.426.3 +
3.90.3808Weight (in kgs)53.7 + 5.454.8 + 3.50.5428Height ( in
cms)151.2 + 3.1151.7 + 2.70.4796BMI23.4 + 223.8 + 1.30.4289ASA
RISKASA GROUP PnGROUP Pon%n%I2686.72790II413.3310p0.691Duration of
ProcedureDur of ProcGROUP PnGROUP PoRange80 - 14080
135Mean107.8105.2S.D.15.2 12p0.4898TOTAL INTEROPERATIVE OPIOiD
USEDTot. opiod usedGROUP PnGROUP PoRange130 - 210140
200Mean167163.3S.D.17.417.9p0.3156APFEL SCOREAPFEL SCOREGROUP
PnGROUP PoNo.%No.%32583.327904516.7310Total3010030100RangeMeanS.D.3
43.170.383 43.10.31p0.4513INTENSITY OF NAUSEA ( VAS )INT OF NAUSEA
GROUP PnGROUP Pop0 2 hrs2.43 + 2.214.43+ 1.650.0008 2 6 hrs
1.53 + 1.633.07 + 1.310.00046 24 hrs
1.3 + 1.662.3 + 1.520.003424 72 hrs
0.9 + 1.492.07 + 1.510.0013EMETIC EPISODES 0 24 HR
IntervalEMETICEPISODESGROUP PnGROUP
Pon%n%YES1033.32273.3NO2066.7826.7p0.0044EMETIC EPISODES 24 72 HR
IntervalEMETICEPISODESGROUP PnGROUP
Pon%n%YES826.71033.3NO2273.32066.7p0.7763COMPLETE REMISSION 0 24 HR
IntervalCOMPLETE REMISSIONGROUP PnGROUP
Pon%n%YES2066.7826.7NO1033.32273.3p0.0044 COMPLETE REMISSION 24 -
72HR IntervalCOMPLETE REMISSIONGROUP PnGROUP
Pon%n%YES2273.32070NO826.71030p0.7763SUMMARYRandomised controlled
study Two groups, 30 patients in eachFemale patients ,non-smokers
,undergoing laproscopy of more than one hour duration receiving
opioids for postoperative pain reliefInj.Palonosetron 0.075 mg Vs
PlaceboData 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 haveSignificant 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 hrsNo
significant difference in Emetic episodes and complete remission
over 24-72hr periodTreatment effect of PALONOSETRON in this trial
was most pronounced during the first 24 h No side effects
26CONCLUSIONPALONOSETRON 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 effectsIn 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;107:44551)28THANK YOU29OBSERVATIONS
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 contdp
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