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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: ondansetron 4 mg; Drug: Metoclopramide 10mg; Drug: Dexamethasone (intravenous)

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Asifa Saeed, MBBS; FCPS; Phone Number: +923006694460; Email: drasifasaeed@gmail.com
• Study Contact Backup: Name: Huda Ather, MBBS; Phone Number: +923047922909; Email: atherhudaather@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Faisalābad, Punjab Province, Pakistan, 38000
      • Faisalabad Medical University
      • Contact: Asifa Saeed, MBBS; FCPS; Phone Number: +923006694460; Email: drasifasaeed@gmail.com
      • Contact: Huda Ather, MBBS; Phone Number: +923047922909; Email: atherhudaather@gmail.com
      • Principal Investigator: Asifa Saeed, MBBS; FCPS
      • Sub-Investigator: Huda Ather, MBBS
      • Sub-Investigator: M. Ibtisam Ahmad, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Ondansetron and Metoclopramide)- Separate syringes; Participants receive; Ondansetron (4 mg IV) and; Metoclopramide (10 mg IV), in two separate colorless syringes, 5-10 minutes before the induction of general anesthesia.	Drug: ondansetron 4 mg; 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; Drug: Metoclopramide 10mg; 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
Active Comparator: Group B (Dexamethasone and Metoclopramide)- Separate syringes; Participants receive; Dexamethasone 8mg IV and; Metoclopramide 10mg IV, in two separate colorless syringes, 5-10 minutes before the induction of general anesthesia.	Drug: Metoclopramide 10mg; 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; Drug: Dexamethasone (intravenous); 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; Fortecortin; Oradexon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Rescue Antiemetic (in minutes)	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).	First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Rescue Doses Required	Total number of rescue antiemetic (metoclopramide 10 mg IV) doses administered to each patient within the first 24 hours.	First 24 hours after surgery
Incidence of PONV	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.	24 hours post-surgery
Severity of Postoperative Nausea and Vomiting (RINVR Score)	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.	Measured at 2, 6, 12, and 24 hours post-surgery
Patient Satisfaction with Antiemetic Treatment	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.	At hospital discharge (approximately 24 hours post-surgery)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Proportion of patients experiencing any adverse reaction including allergic reaction, headache, perineal burning, dystonia, or QT prolongation on post-operative ECG.	From drug administration up to 24 hours post-surgery

Collaborators and Investigators

• Sponsor: Faisalabad Medical University
• Investigators: Principal Investigator: Asifa Saeed, MBBS; FCPS, Faisalabad Medical University

Publications and helpful links

General Publications

• Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
• Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.
• Mishriky BM, Habib AS. Metoclopramide for nausea and vomiting prophylaxis during and after Caesarean delivery: a systematic review and meta-analysis. Br J Anaesth. 2012 Mar;108(3):374-83. doi: 10.1093/bja/aer509. Epub 2012 Feb 3.
• Weibel S, Rucker G, Eberhart LH, Pace NL, Hartl HM, Jordan OL, Mayer D, Riemer M, Schaefer MS, Raj D, Backhaus I, Helf A, Schlesinger T, Kienbaum P, Kranke P. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD012859. doi: 10.1002/14651858.CD012859.pub2.
• Alam, M. S., et al. (2025). Haloperidol Versus Dexmedetomidine As An Adjuvant to Ondansetron in Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy. Egyptian Journal of Surgery, 44(2), 456-463
• Abel UR, Jensen K, Karapanagiotou-Schenkel I, Kieser M. Some Issues of Sample Size Calculation for Time-to-Event Endpoints Using the Freedman and Schoenfeld Formulas. J Biopharm Stat. 2015;25(6):1285-311. doi: 10.1080/10543406.2014.1000546. Epub 2015 Jan 28.
• Naguib M, el Bakry AK, Khoshim MH, Channa AB, el Gammal M, el Gammal K, Elhattab YS, Attia M, Jaroudi R, Saddique A. Prophylactic antiemetic therapy with ondansetron, tropisetron, granisetron and metoclopramide in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind comparison with placebo. Can J Anaesth. 1996 Mar;43(3):226-31. doi: 10.1007/BF03011739.
• Chattopadhyay S, Biswas A, SK Samim Ferdows, Bhowmik DK, Dey S, Bi B. Comparison of Ondansetron, Dexamethasone and Ondansetron Plus Dexamethasone For The Prevention of Post-operative Nausea and Vomiting after Laparoscopic Cholecystectomy. Indian Journal of Clinical Anaesthesia. 2025;3(3):459-463. Accessed April 6, 2026.
• Korkusuz M, Et T. Effect of perioperative restrictive and liberal fluid regimens on postoperative nausea-vomiting and quality of recovery in laparoscopic cholecystectomy. World J Gastrointest Surg. 2025 Oct 27;17(10):110543. doi: 10.4240/wjgs.v17.i10.110543.
• Si XY, Wu LP, Li XD, Li B, Zhou YM. Dexamethasone combined with other antiemetics for prophylaxis after laparoscopic cholecystectomy. Asian J Surg. 2015 Jan;38(1):21-7. doi: 10.1016/j.asjsur.2014.04.005. Epub 2014 Jun 15.
• Ko-Iam W, Sandhu T, Paiboonworachat S, Pongchairerks P, Junrungsee S, Chotirosniramit A, Chotirosniramit N, Chandacham K, Jirapongcharoenlap T. Metoclopramide, versus its combination with dexamethasone in the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy: a double-blind randomized controlled trial. J Med Assoc Thai. 2015 Mar;98(3):265-72.
• Gan TJ, Jin Z, Ayad S, Belani KG, Habib AS, Meyer TA, Urman RD, Andrew BY, Bergese SD, Chung F, Diemunsch P, Kovac AL, Candiotti K, Englesakis M, Grant MC, Hedrick TL, Huang H, Kranke P, Lloyd SJ, Manahan MA, Minkowitz HS, Philip BK, Phillips BJ, Simpson KD, Stever J. Fifth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting: Executive Summary. Anesth Analg. 2025 Nov 14. doi: 10.1213/ANE.0000000000007816. Online ahead of print. No abstract available.

Helpful Links

• STROBE stands for an international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers and journal editors involved in the conduct and dissemination of observational studies, with the common aim of STrengthening the R

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: PONV; Postoperative vomiting; Postoperative nausea; Postoperative emesis
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydroxy Acids; Hydrocarbons, Aromatic; Polycyclic Compounds; Imidazoles; Amides; Indoles; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Phenols; Benzene Derivatives; Sulfonic Acids; Sulfur Acids; Pregnadienetriols; Acids, Carbocyclic; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; para-Aminobenzoates; Aminobenzoates; Benzoates; Hydroxybenzoates; Heterocyclic Compounds, 3-Ring; Phenyl Ethers; Benzamides; Chlorobenzoates; Carbazoles; Hydroxybenzoate Ethers; Dexamethasone; Ondansetron; Metoclopramide; Calcium Dobesilate; dexamethasone acetate
• Other Study ID Numbers: 48/ERC/FMU/2025-26/343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study is single-centre, small and unfunded. Only aggregated, de-identified, summary data will besshared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No