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EVALUATION OF EFFICACY OF PALONOSETRON VERSUS PLACEBO FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING CO-AUTHORS Prof & HOD Dr.I.Chandrasekaran.

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Presentation on theme: "EVALUATION OF EFFICACY OF PALONOSETRON VERSUS PLACEBO FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING CO-AUTHORS Prof & HOD Dr.I.Chandrasekaran."— Presentation transcript:

1 EVALUATION OF EFFICACY OF PALONOSETRON VERSUS PLACEBO FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING CO-AUTHORS Prof & 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. PG INSTITUTE OF ANAESTHESIOLOGY , Madurai Medical College

2 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.

3 RISK FACTORS APFEL Simplified risk scoring for adults

4 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

5 MECHANISM OF ACTION Antagonism of 5HT3 receptors
Also has an allosteric binding site Causes receptor interanalisation and prolonged inhibition

6 USES Prevention of postoperative nausea and vomiting
Prevention of acute and delayed nausea and vomiting associated chemotherapy. Dosage and Administration Postoperative Nausea and Vomiting IV 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.

7 SIDE EFFECTS COMMON 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.

8 AIM To evaluate the efficacy of Palonosetron versus placebo for prevention of Postoperative Nausea and Vomiting

9 DESIGN Randomized double blind control study
Female patients undergoing laproscopic surgery under GA Inclusion criteria Age 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

10 METHODS Ethical 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

11 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

12 DATA COLLECTION EMETIC 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 – 24 hrs & 24 – 72 hrs

13 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

14 ANALYSIS OF COLLECTED DATA

15 Physiological parameters
VARIABLE GROUP Pn (n = 30) GROUP Po “p” Age in years 0.3808 Weight (in kgs) 0.5428 Height ( in cms) 0.4796 BMI 0.4289

16 ASA RISK ASA GROUP Pn GROUP Po n % I 26 86.7 27 90 II 4 13.3 3 10 ‘p’
0.691

17 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

18 TOTAL INTEROPERATIVE OPIOiD USED
Tot. opiod used GROUP Pn GROUP Po Range 140 – 200 Mean 167 163.3 S.D. 17.4 17.9 ‘p’ 0.3156

19 APFEL SCORE APFEL SCORE GROUP Pn GROUP Po No. % 3 25 83.3 27 90 4 5
16.7 10 Total 30 100 Range Mean S.D. 3 – 4 3.17 0.38 3.1 0.31 ‘p’ 0.4513

20 INTENSITY OF NAUSEA ( VAS )
INT OF NAUSEA GROUP Pn GROUP Po “p” 0 – 2 hrs 0.0008 2 – 6 hrs 0.0004 6 – 24 hrs 0.0034 24 – 72 hrs 0.0013

21 EMETIC EPISODES 0 – 24 HR Interval
GROUP Pn GROUP Po n % YES 10 33.3 22 73.3 NO 20 66.7 8 26.7 “p” 0.0044

22 EMETIC EPISODES 24 – 72 HR Interval
GROUP Pn GROUP Po n % YES 8 26.7 10 33.3 NO 22 73.3 20 66.7 “p” 0.7763

23 COMPLETE REMISSION 0 – 24 HR Interval
GROUP Pn GROUP Po n % YES 20 66.7 8 26.7 NO 10 33.3 22 73.3 “p” 0.0044

24 COMPLETE REMISSION 24 - 72HR Interval
GROUP Pn GROUP Po n % YES 22 73.3 20 70 NO 8 26.7 10 30 “p” 0.7763

25 SUMMARY Randomised 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 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

26 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

27 CONCLUSION PALONOSETRON 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 hr it has the advantage of having good control of intensity of nausea

28 REFERENCES A 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)

29 THANK YOU

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32 OBSERVATIONS >0.05 insignificant >0.05 insignificant
‘ 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

33 OBSERVATIONS contd < 0.05 significant < 0.05 significant
‘p ‘ value for VAS scoring of nausea in the interval – 2 hr ( p=0.0008) 2 – 6 hr (p=0.0004) 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 significant > 0.05 insignificant


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