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Recruiting NCT07638527

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

Conditions: Postoperative Nausea and Vomiting

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 264
Sponsor: Faisalabad Medical University

Location: Faisalabad Medical University Faisalābad Punjab Province

Summary

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

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07638527). StuddyBuddy aggregates publicly available trial information.