Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy

Официальное название

Time-to-first-rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy: a Randomized, Triple-Blind, Superiority Trial

Обзор

The goal of this superiority randomized controlled trial (RCT) is to learn if one dual-drug arm increases patient comfort (time to needing rescue medication for nausea/vomiting) more effectively than the other in adults with Moderate-to-High PONV risk (Apfel score 2-4) undergoing elective laparoscopic cholecystectomy (gallbladder surgery). The main question this study aims to answer is: • Does Ondansetron plus Metoclopramide prolong time to first rescue antiemetic more than Dexamethasone plus Metoclopramide? Researchers will compare Group A (Ondansetron 4mg plus Metoclopramide 10mg IV) to Group B (Dexamethasone 8mg IV plus Metoclopramide 10mg IV) to see if Group A provides a longer time to first rescue medication. Participants will: * Receive their assigned, blinded drug group 5-10 minutes before general anesthesia induction. * Receive rescue Metoclopramide 10mg IV if they experience any vomiting or severe nausea * Be monitored for 24 hours post-surgery in the hospital * Report nausea severity at 2, 6, 12 and 24 hours post-surgery

Вмешательства

• Препарат ondansetron 4 mg
  Ondansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
• Препарат Dexamethasone (intravenous)
  Dexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
• Препарат Metoclopramide 10mg
  Metoclopramide 10 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia as part of dual-agent PONV prophylaxis. Also used as rescue antiemetic (10 mg IV) if patient has vomiting or VRS \>4 for nausea.

Первичные конечные точки

• Time to First Rescue Antiemetic (in minutes) [Срок оценки: First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)]

Вторичные конечные точки (4)

• Incidence of PONV [Срок оценки: 24 hours post-surgery]
• Severity of Postoperative Nausea and Vomiting (RINVR Score) [Срок оценки: Measured at 2, 6, 12, and 24 hours post-surgery]
• Number of Rescue Doses Required [Срок оценки: First 24 hours after surgery]
• Patient Satisfaction with Antiemetic Treatment [Срок оценки: At hospital discharge (approximately 24 hours post-surgery)]

Критерии участия

Критерии включения

• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) physical status I or II
• Scheduled for elective laparoscopic cholecystectomy
• Apfel score 2-4 (moderate to high risk for PONV)
• Provides written informed consent prior to enrollment

Критерии исключения

• Known allergy or hypersensitivity to ondansetron, dexamethasone, or metoclopramide
• Emergency surgery (e.g., acute cholecystitis, perforation, or gangrene)
• Pregnancy or breastfeeding
• ASA physical status III or IV
• Preexisting hepatic impairment
• Baseline corrected QT (QTc) interval > 420 ms on pre-operative ECG
• History of dystonic reaction to metoclopramide or other dopamine antagonists
• Preexisting renal impairment (e.g., serum creatinine > 1.5 mg/dL or on dialysis)
• Unable or unwilling to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Пакистан · 1 центр

• Faisalabad Medical University — Faisalābad

Публикации

• Alam, M. S., et al. (2025). Haloperidol Versus Dexmedetomidine As An Adjuvant to Ondansetron in Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy. Egyptian Journal of Surgery, 44(2), 456-463
• Abel UR, Jensen K, Karapanagiotou-Schenkel I, Kieser M. Some Issues of Sample Size Calculation for Time-to-Event Endpoints Using the Freedman and Schoenfeld Formulas. J Biopharm Stat. 2015;25(6):1285-311. doi: 10.1080/10543406.2014.1000546. Epub 2015 Jan 28. PMID 25629760
• Naguib M, el Bakry AK, Khoshim MH, Channa AB, el Gammal M, el Gammal K, Elhattab YS, Attia M, Jaroudi R, Saddique A. Prophylactic antiemetic therapy with ondansetron, tropisetron, granisetron and metoclopramide in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind comparison with placebo. Can J Anaesth. 1996 Mar;43(3):226-31. doi: 10.1007/BF03011739. PMID 8829860
• Chattopadhyay S, Biswas A, SK Samim Ferdows, Bhowmik DK, Dey S, Bi B. Comparison of Ondansetron, Dexamethasone and Ondansetron Plus Dexamethasone For The Prevention of Post-operative Nausea and Vomiting after Laparoscopic Cholecystectomy. Indian Journal of Clinical Anaesthesia. 2025;3(3):459-463. Accessed April 6, 2026.
• Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4. PMID 22263004
• Korkusuz M, Et T. Effect of perioperative restrictive and liberal fluid regimens on postoperative nausea-vomiting and quality of recovery in laparoscopic cholecystectomy. World J Gastrointest Surg. 2025 Oct 27;17(10):110543. doi: 10.4240/wjgs.v17.i10.110543. PMID 41178893
• Si XY, Wu LP, Li XD, Li B, Zhou YM. Dexamethasone combined with other antiemetics for prophylaxis after laparoscopic cholecystectomy. Asian J Surg. 2015 Jan;38(1):21-7. doi: 10.1016/j.asjsur.2014.04.005. Epub 2014 Jun 15. PMID 24942194
• Mishriky BM, Habib AS. Metoclopramide for nausea and vomiting prophylaxis during and after Caesarean delivery: a systematic review and meta-analysis. Br J Anaesth. 2012 Mar;108(3):374-83. doi: 10.1093/bja/aer509. Epub 2012 Feb 3. PMID 22307240

Идентификаторы

NCT: NCT07638527 · 48/ERC/FMU/2025-26/343

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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