NCT07638527 Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy
| NCT ID | NCT07638527 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Faisalabad Medical University |
| Condition | Postoperative Nausea and Vomiting |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2026-09 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 264 participants in total. It began in 2026-09 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Asifa Saeed, MBBS; FCPS
PRINCIPAL INVESTIGATOR
Faisalabad Medical University
Frequently Asked Questions
Who can join the NCT07638527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Nausea and Vomiting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07638527 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07638527 currently recruiting?
Yes, NCT07638527 is actively recruiting participants. Contact the research team at drasifasaeed@gmail.com for enrollment information.
Where is the NCT07638527 trial being conducted?
This trial is being conducted at Faisalābad, Pakistan.
Who is sponsoring the NCT07638527 clinical trial?
NCT07638527 is sponsored by Faisalabad Medical University. The principal investigator is Asifa Saeed, MBBS; FCPS at Faisalabad Medical University. The trial plans to enroll 264 participants.