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NCT Number: NCT07638527

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

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

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faisalabad Medical University

Faisalābad, Punjab Province, 38000, Pakistan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ondansetron 4 MG

Drug

Ondansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.

Other names: Zofran, Zophren, Onmax

Dexamethasone (intravenous)

Drug

Dexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.

Other names: Decadron, Oradexon, Fortecortin

Metoclopramide 10mg

Drug

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.

Other names: Maxolon, Reglan, Paspertin

Primary outcomes

  1. Time to First Rescue Antiemetic (in minutes)

    Time frame: First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)

    Time in minutes from patient arrival to Post-anaesthesia care unit, PACU (time zero) to administration of rescue metoclopramide 10 mg IV. Rescue is given if patient experiences any episode of vomiting/retching or reports a nausea Verbal Rating Scale (VRS) score >4. VRS scale is no nausea (0), mild (1-3), moderate (4-6), and severe (7-10).

Secondary outcomes

  1. Incidence of PONV

    Time frame: 24 hours post-surgery

    Proportion of patients experiencing any nausea (VRS >1) or any vomiting/retching episode within the first 24 hours post-surgery.

    Verbal Rating Scale (VRS) is a well established measurement scale with a total of 11 points where 0 = no nausea and 10 = worst possible nausea.

  2. Severity of Postoperative Nausea and Vomiting (RINVR Score)

    Time frame: Measured at 2, 6, 12, and 24 hours post-surgery

    Measured using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). It evaluates 8 dimensions: frequency/duration/distress of nausea; frequency/amount/distress of vomiting; and frequency/distress of retching. Total score range is 0-32, with 0 indicating no nausea, 1-8 mild, 9-16 moderate, 17-24 severe, and 25-32 great nausea. The higher scores indicate worse PONV.

  3. Number of Rescue Doses Required

    Time frame: First 24 hours after surgery

    Total number of rescue antiemetic (metoclopramide 10 mg IV) doses administered to each patient within the first 24 hours.

  4. Patient Satisfaction with Antiemetic Treatment

    Time frame: At hospital discharge (approximately 24 hours post-surgery)

    Patient-reported satisfaction measured on a 5-point Likert scale (Very Dissatisfied to Very Satisfied) at the end of hospital stay.

    Likert scale is a 5-point psychometric survey scale, with 1 indicating very disappointing and 5 indicating very satisfying. The higher the score, the better the treatment was.

Other outcomes

  1. Adverse Events

    Time frame: From drug administration up to 24 hours post-surgery

    Proportion of patients experiencing any adverse reaction including allergic reaction, headache, perineal burning, dystonia, or QT prolongation on post-operative ECG.

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Sponsors and collaborators

Lead sponsor

Faisalabad Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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