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E VALUATION OF EFFICACY OF PALONOSETRON VERSUS PLACEBO FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING

E VALUATION 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

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E VALUATION OF EFFICACY OF PALONOSETRON VERSUS PLACEBO FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING

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  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 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.

  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 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

  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 0 – 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

  16. ASA RISK

  17. Duration of Procedure

  18. TOTAL INTEROPERATIVE OPIOiD USED

  19. APFEL SCORE

  20. INTENSITY OF NAUSEA ( VAS )

  21. EMETIC EPISODES 0 – 24 HR Interval

  22. EMETIC EPISODES 24 – 72 HR Interval

  23. COMPLETE REMISSION 0 – 24 HR Interval

  24. COMPLETE REMISSION 24 - 72HR Interval

  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 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

  26. OBSERVATIONS • Patients receiving Palonosetroncompared 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 24-72 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(AnesthAnalg 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(AnesthAnalg 2008;107:445–51)

  29. THANK YOU

  30. 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

  31. 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)

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