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

NCT07813897 | Completed Phase 4

• 1 other identifier: BSMMU/2025/12379
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative nausea vomiting; Efficacy; Palanosetron; Dexamethason; Gynaecological laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting

  Occurrence of nausea and vomiting episodes during the postoperative period (0-24 hours).

  24 hours after surgery

Secondary Outcomes (9)

• Severity of postoperative nausea and vomiting

  1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after surgery

• Requirement of rescue antiemetic medication

  During the first 24 hours after surgery

• Incidence of adverse effects related to study drugs

  During the first 24 hours after surgery

• Patient satisfaction after surgery

  At 24 hours after surgery

• Postoperative systolic blood pressure (SBP)

  At 1, 6, 12, and 24 hours after surgery

Study Arms (2)

Palonosetron and Dexamethasone

EXPERIMENTAL

Participants receive palonosetron 0.075 mg IV combined with dexamethasone 5 mg IV before induction of general anaesthesia.

Drug: Palonosetron and Dexamethason

.Palanosetron alone

ACTIVE COMPARATOR

Participants receive palonosetron 0.075 mg IV before induction of general anaesthesia

Drug: Palonosetron

Interventions

Palonosetron and Dexamethason DRUG

Participants receive palonosetron 0.075 mg IV combined with dexamethasone 5 mg IV before induction of general anaesthesia.

Palonosetron and Dexamethasone

Palonosetron DRUG

Participants receive palonosetron 0.075 mg IV before induction of general anaesthesia.

.Palanosetron alone

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing gynaecological laparoscopic surgery
• ASA physical status I and II
• Age 20-40 years
• Provided informed consent

You may not qualify if:

• Pregnancy
• Menstruation
• Gastroesophageal reflux disease
• BMI \>35 kg/m²
• Allergy or contraindication to study drug

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, 100, Bangladesh

Location

Related Publications (17)

• 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.

  PMID: 30013436 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.

  PMID: 32547178 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.

  PMID: 26045930 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.

  PMID: 24280811 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.

  PMID: 21982171 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.

  PMID: 21672343 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.

  PMID: 23543732 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.

  PMID: 35505760 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.

  PMID: 23814652 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.

  PMID: 40348596 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.

  PMID: 31031483 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.

  PMID: 35110042 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.

  PMID: 40046699 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.

  PMID: 26366258 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.

  PMID: 36846536 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.

  PMID: 31198253 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.

  PMID: 34348668 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• AKM Akhtaruzzaman, MD

  Bangladesh Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AssistantProfessor

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 10, 2026
• Study Start: September 10, 2025
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)