Efficacy of Palonosetron Plus Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Gynaecological Laparoscopic Surgery

Summary

Postoperative nausea and vomiting (PONV) is a common complication after general anaesthesia, especially among female patients undergoing laparoscopic surgery. This randomized controlled trial evaluates whether combined palonosetron and dexamethasone is more effective than palonosetron alone in preventing postoperative nausea and vomiting after gynaecological laparoscopic surgery. Eligible patients will be randomized into two parallel groups. The intervention group will receive palonosetron plus dexamethasone, while the comparator group will receive palonosetron alone. Patients will be followed for 24 hours after surgery for incidence and severity of nausea and vomiting, rescue antiemetic requirement, adverse effects, patient satisfaction, and haemodynamic parameters.

Timeline

Start

2025-09-10

Primary completion

2026-05-30

Completion

2026-05-30

Publications

• Background Cho E, Kim DH, Shin S, Kim SH, Oh YJ, Choi YS. Efficacy of Palonosetron-Dexamethasone Combination Versus Palonosetron Alone for Preventing Nausea and Vomiting Related to Opioid-Based Analgesia: A Prospective, Randomized, Double-blind Trial. Int J Med Sci. 2018 Jun 13;15(10):961-968. doi: 10.7150/ijms.24230. eCollection 2018.
• Background Minkowitz H, Leiman D, Lu L, Reines S, Ryan M, Harnett M, Singla N. IV Tramadol - A New Treatment Option for Management of Post-Operative Pain in the US: An Open-Label, Single-Arm, Safety Trial Including Various Types of Surgery. J Pain Res. 2020 May 22;13:1155-1162. doi: 10.2147/JPR.S251175. eCollection 2020.
• Background Ryoo SH, Yoo JH, Kim MG, Lee KH, Kim SI. The effect of combination treatment using palonosetron and dexamethasone for the prevention of postoperative nausea and vomiting versus dexamethasone alone in women receiving intravenous patient-controlled analgesia. Korean J Anesthesiol. 2015 Jun;68(3):267-73. doi: 10.4097/kjae.2015.68.3.267. Epub 2015 May 28.
• Background Bala I, Bharti N, Murugesan S, Gupta R. Comparison of palonosetron with palonosetron-dexamethasone combination for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Minerva Anestesiol. 2014 Jul;80(7):779-84. Epub 2013 Nov 26.
• 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 Park SK, Cho EJ. A randomized, double-blind trial of palonosetron compared with ondansetron in preventing postoperative nausea and vomiting after gynaecological laparoscopic surgery. J Int Med Res. 2011;39(2):399-407. doi: 10.1177/147323001103900207.
• Background Laha B, Hazra A, Mallick S. Evaluation of antiemetic effect of intravenous palonosetron versus intravenous ondansetron in laparoscopic cholecystectomy: a randomized controlled trial. Indian J Pharmacol. 2013 Jan-Feb;45(1):24-9. doi: 10.4103/0253-7613.106430.
• Background Balyan R, Kumar S, Lalitha K, Aneja S, George J. A Randomised Study To Compare Palonosetron With Ondansetron for Prophylaxis of Postoperative Nausea and Vomiting (PONV) Following Laparoscopic Gynecological Surgeries. Cureus. 2022 Mar 29;14(3):e23615. doi: 10.7759/cureus.23615. eCollection 2022 Mar.
• Background Kim SH, Hong JY, Kim WO, Kil HK, Karm MH, Hwang JH. Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study. Korean J Anesthesiol. 2013 Jun;64(6):517-23. doi: 10.4097/kjae.2013.64.6.517. Epub 2013 Jun 24.
• Background Xu H, Rong L, Yang S, Xing J, Dong H, Liu H, Chen X, Liu L. 5-HT3 receptor antagonists for preventing postoperative nausea and vomiting after gynecological surgery: A systematic review and network meta-analysis. Int J Gynaecol Obstet. 2025 Oct;171(1):177-189. doi: 10.1002/ijgo.70197. Epub 2025 May 9.
• Background Reddy GS, Manjusruthi B, Jyothsna G. Postoperative Nausea and Vomiting Prophylaxis: A Comparative Study of Ramosetron and Palonosetron in Patients Undergoing Laparoscopic Cholecystectomy - A Prospective Randomized Trial. Anesth Essays Res. 2019 Jan-Mar;13(1):68-72. doi: 10.4103/aer.AER_192_18.
• Background Khan MA, Gupta A, Gupta N, Mitra M. Efficacy of Palonosetron and Dexamethasone for Prevention of Post-operative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomised Double-Blind Trial. Turk J Anaesthesiol Reanim. 2021 Oct;49(5):400-406. doi: 10.5152/TJAR.2021.191.
• Background Lal B, Alagarsamy R, Kumar J, Rai AJ, Yadav V, Joshi R, Yunus M. Comparison of efficacy and safety between palonosetron and ondansetron to prevent postoperative nausea and vomiting in patients undergoing non-laparoscopic surgery: A systematic review and meta-analysis of randomised controlled trials. Indian J Anaesth. 2025 Jan;69(1):108-122. doi: 10.4103/ija.ija_1017_24. Epub 2025 Jan 11.
• Background Sharma AN, Shankaranarayana P. Postoperative Nausea and Vomiting: Palonosetron with Dexamethasone vs. Ondansetron with Dexamethasone in Laparoscopic Hysterectomies. Oman Med J. 2015 Jul;30(4):252-6. doi: 10.5001/omj.2015.51.
• Background Dey S, Chanu SM, Dev P, Borthakur M, Karim HMR, Yunus M. Antiemetic Efficacy of Palonosetron Compared with the Combination of Ondansetron and Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynaecological Surgery. Rom J Anaesth Intensive Care. 2022 Sep 25;28(1):19-24. doi: 10.2478/rjaic-2021-0003. eCollection 2021 Jul.
• Background Rajnikant K, Bhukal I, Kaloria N, Soni SL, Kajal K. Comparison of Palonosetron and Dexamethasone with Ondansetron and Dexamethasone to Prevent Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy. Anesth Essays Res. 2019 Apr-Jun;13(2):317-322. doi: 10.4103/aer.AER_21_19.
• Background Xu S, Wang S, Hu S, Ju X, Li Q, Li Y. Effects of lidocaine, dexmedetomidine, and their combination infusion on postoperative nausea and vomiting following laparoscopic hysterectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Aug 4;21(1):199. doi: 10.1186/s12871-021-01420-8.

Drugs

Indications

No indication recorded.