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

RecruitingPhase 4Ages 18 Years - anyAllFaisalabad Medical University
NCT07638527 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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: โ€ข 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 experienc

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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
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What it tests

  • ondansetron 4 mg
  • Dexamethasone (intravenous)
  • Metoclopramide 10mg
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Where

1 site
Faisalabad Medical University
Faisalฤbad, Pakistan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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