Title: A Comparasion of Perioperative Ramosetron and Ramosetron with Dexamethasone Prophylaxis for the Prevention of Postoperative Nausea and Vomiting Following Laparoscopic Cholecystectomy under General Anaesthesia
Authors: Rakesh Nongthombam, Ashem Jack Meitei, Sinam Neetu Devi, Prof. Prithwis Bhattacharyya, Maharabam Binarani
DOI: https://dx.doi.org/10.18535/jmscr/v5i4.140
Abstract
Introduction: Post Operative Nausea and Vomiting (PONV) is a well known complication following laparoscopic cholecystectomy under general anaesthesia ranges from 53-72 %. A reduction in the incidence of PONV following laparoscopic cholecystectomy will be highly beneficial for the patients to avoid patient dissatisfaction and peri-operative morbidity. This study have been undertaken to find out the efficacy of combination therapy of ramosetron with dexamethasone for the prevention of PONV following laparoscopic cholecystectomy under general anaesthesia.
Methods: 30 patients in each study group, age 18-65 years of either sex with ASA class I and II, scheduled for elective laparoscopic cholecystectomy under standardized general anaesthesia were enrolled in this randomized, double blind prospective study. Medication was given intravenously immediately before administration of induction agent. Enrolled patients were divided into two groups as RD group (ramosetron 0.3 mg with dexamethasone 6 mg and R group (ramosetron 0.3 mg). The incidence of nausea, and vomiting, severity of nausea and need of rescue antiemetic were studied for the first 24 hours postoperatively at 0-6 hours and 6-24 hours and 0-24 hours.
Results: The incidence of nausea, PONV, rescue antiemetic were reduced in the RD group during 0-6 hours post operative periods while the incidence of vomiting was significantly reduced in RD group during 0-6 hours post operative (P = 0.003). The severity of nausea which measured by VRS was also significantly lesser in the RD group (P = 0.00). There were no clinically significant adverse effects during the study which required intervention. Following the study, patients were reported to have experienced satisfactory postoperative period.
Conclusions: Perioperative prophylaxis of ramosetron with dexamethasone combination given before the induction of anaesthesia is more effective regimen than ramosetron alone in preventing the incidence of PONV after elective laparoscopic cholecystectomy under general anaesthesia.
Keywords: Ramosetron, Dexamethasone, Postoperative nausea and vomiting, Verbal Rating Scale, Laparoscopic Cholecystectomy, General Anaesthesia.
References
1. NIH Consensus Development Panel on Gallstones and Laparoscopic cholecystec-tomy. Gallstones and laparoscopic cholec-ystectomy. JAMA 1993; 269: 1018-24.
2. Begos DG, Modlin IM. Laparoscopic cholecystectomy: from gimmick to gold standard. J Clin Gastroenterol 1994; 19: 325-35.
3. Fredman B, Jedeikin R, Olsfenger D, Flor P, Gruzman A. Residual pneumop-eritoneum, a cause of post operative pain after laparoscopic cholecystectomy. Anaesth Anal 1994; 79: 152-4.
4. Thune A, Appelgren L, Haglind E. Prevention of post operative nausea and vomiting after laparoscopic cholecyste-ctomy. Eur J.Surj. 1995; 161: 265-8.
5. Naguib M, Bakry AK, khoshim MH, Channa AB, Gammal K, Elhattab YS, Attia M, Jaroudi R, Saddique A. Prophylactic antiemetic therapy with ondansetron, tropisetron, granisetron and metoclopramide in patient undergoing laparoscopic cholecystectomy: a randomized double-blind comparison with placebo. Can J.Anaesth1996; 43: 226-31.
6. Koivurauta MK, Laora E and Ryhanen PT. Anti emetic efficacy of prophylactic Ondansetron in laparoscopic cholecyst-ectomy: A randomized, double-blind, placebo controlled trial. Anaesthesia 1996; 51: 52-5.
7. Mraovic B, Jurioic T, Kogler Majeric V, Sustic A. Intra peritoneal bupivacaine for Analgesia after Laparoscopic cholecyste-ctomy. Acta. Anaesthesia, Scand 1997; 41: 193-6.
8. Christian C.Apfel. Post operative nausea and vomiting. Ronald D.Miller. (Eds); Miller Anaesthesia. 7th edition. Philadel-phia, Churchill Livingstone, 2010. pp. 2729-53.
9. Adam k Jacob, Sandra L. Kopp, Douglas R. Bacon and Hugh M.Smith. The history of Anaesthesia. In: Paul G. Barash, Bruce F.Cullen, Robert K. Stoelting, Michael K. Cahalan M.Christine Stock (eds) Clinical Anaesthesia. 6th ed. Philadelphia, WOLTERS KLUWER/LIPPINCOTT WILLIAM & WILKINS, 2009. P-18.
10. Paul H. Ting. Post operative Nausea and vomiting. An overview www.anaesthesiologyinfo.com
11. Rabasseda X. Ramosetron, a 5-HT3 receptor antagonist for the control of nausea and vomiting. Drugs Today (Barc). 2002 Feb; 38(2): 75-89.
12. Gan TJ. Selective Serotonin 5-HT3 receptor antagonist for post operative nausea and vomiting, are they all the same? CNS Drugs 2005; 19: 225-38.
13. Jansen K, Kehlet H and Lund CM. Post operative recovery profile after laparo-scopic cholecystectomy: a prospective observational study of a multi-modal anaesthetic regime.Acta anaesthesiology Scand.2007; 51(4): 464-71.
14. Fujii Y , Saitoh Y , Taneka H , Toyooka H. Comparison of ramosetron and granisetron for preventing PONV after laparoscopic cholecystectomy. Can, Anaesthesia, 1999; 46: 991-93.
15. Ryu J, So YM, Hway J, Do SH. Ramosetron vs. ondansetron for prevention of post operative after laparoscopic. Surg Endos 2010; 24(4): 812-7.
16. Gan TJ. Risk factors for postoperative nausea and vomiting. Anesth. Analg. 2006 Jun; 102(6): 1884-98.
17. Jones AL, Hill AS , Soukop M, Hutcheon AW, Cassidy J and Kaye SB. Comparison of dexamethasone and ondansetron in the prophylaxis of emesis induced by moderately emetogenic chemotherapy. Lancet 1991; 338: 483-7.
18. Watcha MF and white PF. Post operative nausea and vomiting, its aetiology, treatment and prevention. Anaesthesiology 1992; 77(1): 162-8.
19. McKenzie R, Tantisira B, Karambelkar DJ, Riley TJ and Abdelhedy H. Comparison of ondansetron plus saline and ondansetron plus dexamethasone in the prevention of post operative nausea and vomiting. Anaesthesia Analgesia 1994; 75(5): 961-4.
20. Tsukagoshi S. A new antiemetic ramosetron hydrochloride. Gan To Kagaku Ryoho. 1997 Feb; 24(3): 371-80.
21. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Comparison of ramosetron and granisetron for preventing postoperative nausea and vomiting after gynaecologic surgery. Anesth Analg. 1999 Aug; 89(2): 476-9.
22. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Ramosetron vs. granisetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystec-tomy. Can. J Anaesth. 1999 Oct; 46(10): 991-3.
23. Fujii Y, Tanaka H. Double-blind, placebo-controlled, dose-ranging study of ramosetron for the prevention of nausea and vomiting after thyroidectomy. Clin Ther. 2002; 24(7): 1148-53.
24. Fujii Y. Current review of ramosetron in the prevention of postoperative nausea and vomiting. Curr Drug Saf. 2011 Apr; 6(2): 122-7.
25. Ryu JH, Jeon YT, Hwang JW, Oh AY, Moon JY, Ro YJ, Kim CS, Chen C, Apfel CC, Do SH. Intravenous, oral, and the combination of intravenous and oral ramosetron for the prevention of nausea and vomiting after laparoscopic cholecystectomy: a randomized, double-blind, controlled trial. Clin Ther. 2011 Sep; 33(9): 1162-72.
26. Kyubo Kim, Eui Kyu Chie, Jin Young Jang, Sun Whe Kim , Do Youn Oh , Seock Ah Im, Tao You Kim, Yung Jue Bang and Sung W.H. Ramosetron for the prevention of nausea and vomiting during 5-Fluro uracil based chemo radiotherapy for pancreatico- biliary cancer. Jpn j Clin Oncol 2009; 39(2): 111-5.
27. Aapro MS and Alberts DS. High dose dexamethasone for prevention of cisplatin induced vomiting. Cancer Chemother Pharmacol 1981; 7 (1): 11-4.
28. Splinter WM and Robert DJ. Dexamethasone decreased vomiting after elective tonsillectomy in 133 healthy children. Anaesthesia Analgesia. 1996; 83(5): 913-6.
29. Pappas ALS, Sukhani R, Hotaling AJ, Mikatstens M, Javorski JJ and Donzelli J. The effect of preoperative dexamethasone on immediate and delayed post operative morbidity in children undergoing adenotonsillectomy. Anaesthesia Analgesia.1998; 87(1): 57-61.
30. Liu K, Hsu CC and Chia YY. Effect of dexamethasone on post operative emesis and pain. British Journal of Anaesthesia.1998; 80: 85-6.
31. Thue B, Klarskov BRN, Henrik k and Jacob R. Preoperative dexamethasone improves surgical outcome after laparoscopic cholecystectomy: a randomized, double-blind, placebo controlled trial. Annals of surgical.2003; 238(5); 651-60.
32. Scuderi PE, James RL, Harris L, Mims GR. Multimodal antiemetic management prevents early postoperative vomiting after outpatient laparoscopy. Anesth Analg. 2000 Dec; 91(6): 1408-14.
33. Fujii Y, Tanaka H and Toyooka H. Granisetron and dexamethasone combination reduces postoperative nausea and vomiting. Can.J.Anaesth 1995; 42(5pt1): 387-90.
34. Lopez-Olaondo L, Carrascosa f, Pueyo FJ, Mondero P, Busto N and Saez A. Combination of ondansetron and dexamethasone in the prophylaxis of post operative nausea and vomiting. British Journal of Anaesthesia.1996; 76(6): 835-840.
35. Rajeeva V, Bhardwaj N, Batra YK and Dhaliwal LK. Comparison of ondansetron with ondansetron dexamethasone in prevention of PONV in diagnostic laparoscopy. Can J. Anaethe.1999; 46(1): 40-4.
36. Wang JJ, Ho ST, Ven YH, Lin MT, Chen KT, Huang JC and Tzeng JI. Small dose dexamethasone reduces nausea and vomiting after laparoscopic cholecyst-ectomy, a comparison of tropisetron with saline. Anaesthesia Analgesia.2002; 95: 229-32.
37. Biswas BN and Rudra A. Comparison of granisetron and granisetron plus dexamethasone for the prevention of post operative nausea and vomiting after laparoscopic cholecystectomy. Acta anaesthesiology Scand. 2003; 47(1): 79-83.
38. Fujii Y, Tanaka H and Kawasaki T. A randomized, double-blind comparison of granisetron alone and combined with dexamethasone for post laparoscopic cholecystectomy emetic symptom. Current therapeutic research. 2003; 64(8): 514-21.
39. Vovavud N, Sriuranpong. Phase II trial of ramosetron plus dexamethasone in the prevention of cisplatin induced nausea and vomiting. Med Assoc Thai 2005; 88(12): 1790-6.
40. Ching-Liang Ho, Wu-Chou Su, Ruey-Kuen Hsieh, Zhong-Zhe Lin and Tsu-Yi Chao. A randomized, double-blind, parallel, comparative study to evaluate the efficacy and safety of ramosetron plus dexamethasone injection for the prevention of acute chemotherapy-induced nausea and vomiting. Jpn J Clin Oncol 2010; 40(4): 294-301.
41. Jung Hee Ryu, Ji Eun Chang, Hye Rim Kim, Jung Won Hwang, Ah Young Oh, Sang Hwan Do. Ramosetron vs ramosetron plus dexamethasone for the prevention of postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy: Prospective, randomized, and double-blind study. International Journal of surgery 11 (2013) 183-7.
42. Younghoon Jeon, Hyunjee Kim, Kyung Hwa Kwak. Comparison of ramosetron, dexamethasone and a combination of ramosetron and dexamethasone for the prevention of postoperative nausea and vomiting in Korean women undergoing thyroidectomy: A double-blind, randomized, controlled study. Curr Ther Res Clin Exp. 2010; 71: 78-88.
43. Fujii Y, Saitoh Y, Tanaka H and Tayooka H. Granisetron and dexamethasone combination for the prevention of nausea and vomiting after laparoscopic cholecystectomy. Eur. J. Anaesthesiol. 2000; 17: 64-8.
44. Ryu J, So YM, Hwang J, Do SH. Ramosetron versus ondansetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Surg Endosc. 2010 Apr; 24(4): 812-7. Epub 2009 Aug 26.
45. Kim WO, Koo BN, Kim YK, Kil HK. Ramosetron for the prevention of postoperative nausea and vomiting (PONV): a meta-analysis. Korean J Anesthesiol. 2011 Nov; 61(5): 405-12. Epub 2011 Nov 23.
46. Liu YH, Hsu CC and Chia YY. The effective dose of dexamethasone for antiemesis after major gynaecological surgery. Anaesthesia Analgesia.1999; 89: 1316-8.
47. Henze I, Walder B and Tramer MR. Dexamethasone for the prevention of post operative nausea and vomiting: a quantitative systemic review. Anaesthesia Analgesia.2000; 90: 186-94.
48. Fukudo S, Kinoshita Y, Okumura T, Ida M, Akiho H, Nakashima Y, Nishida A, Haruma K. Ramosetron reduces symptoms of irritable bowel syndrome with diarrhea and improves quality of life in women. Gastroenterology. 2016; 150(2): 358-66.
49. Cohen MM, Duncan PG, DeBoer DP, Tweed WA. The postoperative interview: assessing risk factors for nausea and vomiting. Anesth Analg. 1994; 78: 7-16.