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

NCT07638527 | Not Yet Recruiting Phase 4

• 1 other identifier: 48/ERC/FMU/2025-26/343
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; Postoperative emesis; Postoperative nausea; Postoperative vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of PONV

  24 hours post-surgery

• Severity of Postoperative Nausea and Vomiting (RINVR Score)

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

• Number of Rescue Doses Required

  First 24 hours after surgery

• Patient Satisfaction with Antiemetic Treatment

  At hospital discharge (approximately 24 hours post-surgery)

Other Outcomes (1)

• Adverse Events

  From drug administration up to 24 hours post-surgery

Study Arms (2)

Group A (Ondansetron and Metoclopramide)- Separate syringes

EXPERIMENTAL

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; Drug: Metoclopramide 10mg

Group B (Dexamethasone and Metoclopramide)- Separate syringes

ACTIVE COMPARATOR

Participants receive * Dexamethasone 8mg IV and * Metoclopramide 10mg IV, in two separate colorless syringes, 5-10 minutes before the induction of general anesthesia.

Drug: Dexamethasone (intravenous); Drug: Metoclopramide 10mg

Interventions

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.

Also known as: Zofran, Zophren, Onmax

Group A (Ondansetron and Metoclopramide)- Separate syringes

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.

Also known as: Decadron, Oradexon, Fortecortin

Group B (Dexamethasone and Metoclopramide)- Separate syringes

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.

Also known as: Maxolon, Reglan, Paspertin

Group A (Ondansetron and Metoclopramide)- Separate syringes; Group B (Dexamethasone and Metoclopramide)- Separate syringes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faisalabad Medical University: lead

Study Sites (1)

Faisalabad Medical University

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (12)

• 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

  BACKGROUND

• 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.

  PMID: 25629760 BACKGROUND

• 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.

  PMID: 8829860 BACKGROUND

• 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.

  BACKGROUND

• Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.

  PMID: 22263004 BACKGROUND

• 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.

  PMID: 41178893 BACKGROUND

• 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.

  PMID: 24942194 BACKGROUND

• 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.

  PMID: 22307240 BACKGROUND

• 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.

  PMID: 25920297 BACKGROUND

• 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.

  PMID: 41237407 BACKGROUND

• 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.

  PMID: 10485781 BACKGROUND

• 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.

  PMID: 33075160 BACKGROUND

Related 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

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron; Dexamethasone; Calcium Dobesilate; dexamethasone acetate; Metoclopramide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Phenyl Ethers; Phenols

Study Officials

• Asifa Saeed, MBBS; FCPS

  Faisalabad Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asifa Saeed, MBBS; FCPS

CONTACT

+923006694460; drasifasaeed@gmail.com

Huda Ather, MBBS

CONTACT

+923047922909; atherhudaather@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department Anaesthesiology and Critical Care, AHF-1

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)