drugset / Trial / NCT06886230
Ondansetron vs. Dexamethasone for Postoperative Nausea
Phase 4
Completed
105 enrolled
Hafiz Muhammad Hamza
Federal Government Polyclinic (Postgraduate Medical Institute) · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This randomized controlled trial aims to evaluate the safety and efficacy of Ondansetron, Dexamethasone, and their combination in managing postoperative nausea and vomiting (PONV) in patients undergoing surgery under anesthesia. A total of 100 patients will be randomized into four groups: Placebo, Ondansetron, Dexamethasone, and Ondansetron-Dexamethasone combination. The primary outcome will be the incidence of PONV within 24 hours post-surgery, while secondary outcomes include severity of symptoms, need for rescue medication, adverse effects, and patient satisfaction.
Timeline
- Start
- 2025-03-20
- Primary completion
- 2025-06-10
- Completion
- 2025-06-11
Publications
- Background Bhattarai B, Shrestha S, Singh J. Comparison of ondansetron and combination of ondansetron and dexamethasone as a prophylaxis for postoperative nausea and vomiting in adults undergoing elective laparoscopic surgery. J Emerg Trauma Shock. 2011 Apr;4(2):168-72. doi: 10.4103/0974-2700.82200.
- Background Thanuja IL, Parida S, Mishra SK, Badhe AS. Effect of combinations of dexamethasone-ondansetron and dexamethasone-ondansetron-aprepitant versus aprepitant alone for early postoperative nausea and vomiting after day care gynaecological laparoscopy: A randomised clinical trial. Indian J Anaesth. 2021 Jun;65(6):465-470. doi: 10.4103/ija.IJA_119_21. Epub 2021 Jun 22.
- Background Bilgen S, Kizilcik N, Haliloglu M, Yildirim G, Kaspar EC, Koner O. Effect of the Dexamethasone-Ondansetron Combination Versus Dexamethasone-Aprepitant Combination to Prevent Postoperative Nausea and Vomiting. Turk J Anaesthesiol Reanim. 2018 Sep;46(5):373-380. doi: 10.10.5152/TJAR.2018.53179. Epub 2018 Sep 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 8 mg | Intravenous |
| Comparator | Ondansetron | Other / unclassified | 4 mg | Intravenous |
Indications
No indication recorded.