1. COMPARISON OF RAMOSETRON AND ONDANSETRON FOR PREVENTING POST OPERATIVE NAUSEA AND VOMITING AFTER LAPAROSCOPIC SURGERY Dr.T.VANITHA D.A POST-GRADUATE CO-AUTHORS Prof.Dr.N.LATHA M.D.,D.A Prof.Dr.B.CHANDRIKA M.D.,D.A Prof.Dr.A.CHANDRASEKARAN M.D.,D.A COIMBATORE MEDICAL COLLEGE

2. INTRODUCTION  Laparoscopy,compared to conventional surgery reduces the patient morbidity significantly.  PONV increases the duration of hospital stay and morbidity which negates the advantages of laparoscopy  Antiemetic medications which reduces the incidence of PONV is advantageous  The two Antiemetics RAMOSETRON and ONDANSETRON are compared in laparoscopic procedures

3. PONV  PONV are distressing symptoms that often occur after laparoscopic surgery performed under GA.  A number of pharmacologic approaches, antihistamines,butyrophenones,dopamine receptor antagonists but undesirable adverse effects (antihistamines,butyrophenones,dopamine receptor antagonists) have been investigated for the same but undesirable adverse effects such as excessive sedation, hypotension, dry mouth,dysphoria,hallucinations and extrapyramidal symptoms have been noted.

4. PONV…  Ondansetron  Ondansetron a selective 5-hydroxytryptamine type (5-HT3),receptor antagonist reduces the incidence of PONV after laparoscopic surgery.  Ramosetron new  Ramosetron another new 5-HT 3 receptor antagonist is claimed to be potent with longer duration of action.  Hence a comparitive, prospective, randomised, double blinded study is done.

5. AIM OF THE STUDY To evaluate the efficacy and safety of Ramosetron in preventing PONV after laparoscopic surgeries with Ondansetron as the comparative drug.

6. MATERIALS AND METHODS  Institutional review board approval  Informed consent  Total No of Pts - 40  ASA physical status I or II  Aged between 20-60 years  Scheduled for Laparoscopic Cholecystectomy and Laparascopic Appendicectomy

7. MATERIALS AND METHODS GROUP I GROUP II LAP CHOLECYSTECTOMY 9 8 LAP APPENDICECTOMY 11 12

8. EXCLUSION CRITERIA  History of motion sickness  History of previous PONV  Pregnancy  Menstruating patients  Antiemetic medication within 24 hours before surgery.

9. RANDOMISATION  Patients were randomly allocated to receive single dose of one of two treatment regimens (n=20each) Ramosetron 0.3mg,Ondansetron 4mg  Administered IV immediately after surgery  Identical syringes containing each drug was prepared by personnel not involved in the study.

10. TECHNIQUE OF GA  Premed : Inj Glycopyrrolate iv 0.2 mg IM 45 min before surgery.  Induction : Inj propofol 2mg/kg IV  Analgesia : Inj fentanyl 2µg/kg iv  Inj vecuronium 0.2 mg/kg to facilitate tracheal intubation  Maintenance : 66% N2O and 0.5% -2% isoflurane in oxygen  Ventilation mechanically controlled

11. TECHNIQUE OF GA…  ET CO2 - 35 and 40mmHg  Muscle relaxation maintained with vecuronium as required  Naso gastric tube inserted and suction applied to empty the stomach before extubation  Reversal with neostigmine 0.04mg/kg iv and glycopyrrolate 0.01mg/kg  Trachea extubated when awake  Postop analgesia :Inj Diclofenac 6 th hourly IM

12. OBSERVATION  Observation period : 48 hrs  Observed for Nausea, Retching, Vomiting  Episodes of PONV recorded by direct questioning or by spontaneous complaint by the patient during 3 periods 0-3hrs,3-24hrs,24-48hrs

13. OBSERVATION...  Patients were evaluated for the presence of nausea, vomiting and retching and number of episodes of them  Other side effects: headache, dizziness,drowsiness noted.  At the end of each period the patients were evaluated.  Complete response is defined as no PONV and no need for another rescue medication.

14. RESULTS DEMOGRAPHIC DETAILS AGEWT(KG)HT(CM)DUR OF SUR(MIN) DUR OF ANES(MIN) GROUP-I MEAN S.D 31.46 12.49 58.8 6.64 156 4.52 79 15.06 89.66 15 GROUP II MEAN S.D 31.46 10.28 55 7.02 155 4.51 76 13.65 87.33 14.25 STATISTICS [ P VALUE] 0.2720.5600.7880.3020.430

15. INCIDENCE OF PONV NUMBER OF PERSONS-PONV N R V PERCENTAGE OF PERSONS- PONV N R V PERCENT OF COMPLETE RESPONSE GROUP I (RAMOSETRON) 3 2 315 10 1585 GROUP II (ONDANSETRON) 7 2 435 10 2040

16. NUMBER OF EPISODES Pt IPt IIPt IIIPt IV RAMOSETRONRETCHING(2) 1 2 VOMITING(3) 1 1 2 ONDANSETRONRETCHING(2) 1 2 VOMITING(4) 2 1 1 3

17. ANALYSIS OF TIMING OF PONV 0 to 3 Hrs in %3 to 24 Hrs in %24 to 48 Hrs in % N R V G I RAM OSET RON ___13.313.33 _ G II OND ANSE TRON 206.66 46.613.3326.6620_13.33 P value 0.0130.1430.0320.021.00.0480.040.1430.142 Signi/ not signi sig---sig Not sig sig ---Not sig

18. COMPARISON IN THE INITIAL 24Hrs 0 to 3 Hrs 3 to 24 Hrs N R V N R V RAMOSETRON _ _ _13.33% ONDANSETRON20%6.66% 46.66%13.33%26.66%

19. DISCUSSION REVIEW OF LITERATURE  The reference study is the comparison of RAMOSETRON and GRANISETRON for preventing postoperative nausea and vomiting after gynaecologic surgery. Yoshitaka Fujii et al Anesth Analg 1999;89:476-9  Claimed prophylactic therapy with Ramosetron is more effective for the longterm prevention of PONV in major gynaecologic surgery.

20. DISCUSSION….  Another study Comparison of RAMOSETRON and ONDANSETRON for the prevention of nausea and vomiting after gynaecologic surgery  Kim et al,European journal of anaesthesiology june-2006 vol 23,issue p-160  Claimed the antiemetic efficacyof Ramosetron was not different from that of Ondansetron

21. SUMMARY  40 patients 20 in each group  Single dose of the drug administered iv  Observed for a period of 48 hrs  Number of episodes of retching and vomiting noted  No significant side effects noted in both the groups  Complete response in 48 hours RAMOSETRON :85% ONDANSETRON:40%

22. CONCLUSION Ramosetron ismore effective  Prophylactic therapy with Ramosetron is more effective than with Ondansetron in the initial 24 hours following laparosopic surgery.  Hence we conclude that RAMOSETRON is more effective than ONDANSETRON in preventing PONV after laparoscopic surgeries