Time to first rescue antiemetic after two dual-drug regimens for PONV in gallbladder surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 4, randomized, superiority trial comparing two combination antiemetic strategies given before anesthesia in adults with moderate-to-high risk of PONV undergoing elective laparoscopic cholecystectomy. Participants are assigned to either ondansetron 4 mg plus metoclopramide 10 mg IV or dexamethasone 8 mg IV plus metoclopramide 10 mg IV, with the primary outcome being time to first rescue antiemetic within 24 hours post-surgery. The study administers blinded treatment shortly before anesthesia and provides rescue metoclopramide for vomiting or severe nausea, with in-hospital monitoring for 24 hours. The trial aims to determine whether the ondansetron combination provides better PONV control than the dexamethasone combination.

Why it matters

Who can join: the full rules

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

Where it's running

• Faisalabad Medical University
  Faisalābad, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Asifa Saeed, MBBS; FCPS — Faisalabad Medical University
• Study coordinator: Asifa Saeed, MBBS; FCPS
• Email: drasifasaeed@gmail.com
• Phone: +923006694460

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.