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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFaisalabad Medical University

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

264 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faisalabad Medical University Status unavailable 38000, Faisalābad, Punjab ProvincePakistanPakistan

Sponsors and collaborators