Palonosetron vs Ondansetron In PONV Prophylaxis Among Idiopathic Scoliosis Patients

Summary

The goal of this clinical trial is to compare the effectiveness of two antiemetic drugs, palonosetron and ondansetron, when given alongside dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis undergoing posterior spinal fusion surgery under total intravenous anesthesia (TIVA). The main questions the study aims to answer are: * How effective is palonosetron compared to ondansetron, both combined with dexamethasone, in preventing PONV after scoliosis surgery? * Are there any differences in the need for rescue antiemetics, occurrence of adverse effects related to the study drugs, and patient satisfaction between the two treatment groups? Participants in the study will be randomly assigned to receive either palonosetron or ondansetron in addition to dexamethasone as part of their anesthesia and antiemetic regimen. The incidence and/ or severity of nausea, vomiting and retching will be assessed at 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery.

Timeline

Start

2023-06-01

Primary completion

2024-03-20

Completion

2024-05-02

Publications

• Background Kumar A, Solanki SL, Gangakhedkar GR, Shylasree TS, Sharma KS. Comparison of palonosetron and dexamethasone with ondansetron and dexamethasone for postoperative nausea and vomiting in postchemotherapy ovarian cancer surgeries requiring opioid-based patient-controlled analgesia: A randomised, double-blind, active controlled study. Indian J Anaesth. 2018 Oct;62(10):773-779. doi: 10.4103/ija.IJA_437_18.
• Background Kotiniemi LH, Ryhanen PT, Valanne J, Jokela R, Mustonen A, Poukkula E. Postoperative symptoms at home following day-case surgery in children: a multicentre survey of 551 children. Anaesthesia. 1997 Oct;52(10):963-9. doi: 10.1111/j.1365-2044.1997.203-az0338.x.
• Background Villeret I, Laffon M, Duchalais A, Blond MH, Lecuyer AI, Mercier C. Incidence of postoperative nausea and vomiting in paediatric ambulatory surgery. Paediatr Anaesth. 2002 Oct;12(8):712-7. doi: 10.1046/j.1460-9592.2002.00952.x.
• Background Patel RI, Hannallah RS. Anesthetic complications following pediatric ambulatory surgery: a 3-yr study. Anesthesiology. 1988 Dec;69(6):1009-12. doi: 10.1097/00000542-198812000-00044. No abstract available.
• Background Rowley MP, Brown TC. Postoperative vomiting in children. Anaesth Intensive Care. 1982 Nov;10(4):309-13. doi: 10.1177/0310057X8201000402.
• Background Awad IT, Moore M, Rushe C, Elburki A, O'Brien K, Warde D. Unplanned hospital admission in children undergoing day-case surgery. Eur J Anaesthesiol. 2004 May;21(5):379-83. doi: 10.1017/s0265021504005058.
• Background Kovac AL. Update on the management of postoperative nausea and vomiting. Drugs. 2013 Sep;73(14):1525-47. doi: 10.1007/s40265-013-0110-7.
• Background Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.
• Background Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health Syst Pharm. 2005 Jun 15;62(12):1247-60; quiz 1261-2. doi: 10.1093/ajhp/62.12.1247.
• Background Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.
• Background Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
• Background Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002 Feb;88(2):234-40. doi: 10.1093/bja/88.2.234.
• Background Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.
• Background Eberhart LHJ, Geldner G, Kranke P, Morin AM, Schauffelen A, Treiber H, Wulf H. The development and validation of a risk score to predict the probability of postoperative vomiting in pediatric patients. Anesth Analg. 2004 Dec;99(6):1630-1637. doi: 10.1213/01.ANE.0000135639.57715.6C.
• Background Palmer GM, Pirakalathanan P, Skinner AV. A multi-centre multi-national survey of anaesthetists regarding the range of anaesthetic and surgical practices for paediatric scoliosis surgery. Anaesth Intensive Care. 2010 Nov;38(6):1077-84. doi: 10.1177/0310057X1003800619.
• Background Ho CM, Wu HL, Ho ST, Wang JJ. Dexamethasone prevents postoperative nausea and vomiting: benefit versus risk. Acta Anaesthesiol Taiwan. 2011 Sep;49(3):100-4. doi: 10.1016/j.aat.2011.06.002.
• Background Wakamiya R, Seki H, Ideno S, Ihara N, Minoshima R, Watanabe K, Sato Y, Morisaki H. Effects of prophylactic dexamethasone on postoperative nausea and vomiting in scoliosis correction surgery: a double-blind, randomized, placebo-controlled clinical trial. Sci Rep. 2019 Feb 14;9(1):2119. doi: 10.1038/s41598-019-38764-8.
• Background Kloth DD. New pharmacologic findings for the treatment of PONV and PDNV. Am J Health Syst Pharm. 2009 Jan 1;66(1 Suppl 1):S11-8. doi: 10.2146/ashp080462.

Drugs

Indications