A Phase 4 interventional study of ondansetron 4 mg and Dexamethasone (intravenous) in Postoperative Nausea and Vomiting, sponsored by Faisalabad Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Faisalabad Medical University · Phase 4, Interventional, and Prevention
Among 42 studies testing ondansetron in Postoperative Nausea and Vomiting — 2 open to participants now, 3 under way, none of them phase 3. Ondansetron · Postoperative Nausea and Vomiting.
Among the 42 studies testing ondansetron in Postoperative Nausea and Vomiting, this one is the 8th largest by planned enrollment, is one of 2 that started in 2026, is one of 24 in phase 4, and was the 41st registered.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
Browse Postoperative Nausea and Vomiting studies →2 of the 42 studies testing ondansetron in Postoperative Nausea and Vomiting are open now, in 3 countries. Recruiting first, the newest first:
Telethon Kids Institute · Sites in Australia, Brazil
Ages 2–15
By country, each count listing its studies:
Ondansetron: first FDA approval 1991 (ZOFRAN). What it is approved for, and how studies give it, is on its page →
Of the 65 Postoperative Nausea and Vomiting studies recruiting now, 22 (34%) set no upper age limit and 37 (57%) stop at 75 or younger; 14 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 4 · Phase 4 24
First in 2004; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 264 is above the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Median enrollment 121 across the 42 interventional studies. Of the 33 that completed or were terminated, 11 (33%) have results posted.
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4 of 42 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Faisalabad Medical University as lead sponsor.
Faisalabad Medical University has 1 study filed under Postoperative Nausea and Vomiting — fewer than ten, so there is no comparison to draw.
1 of the studies testing ondansetron in Postoperative Nausea and Vomiting that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07638527Faisalabad Medical UniversityTime to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy | 2027-03 |
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Among the 42 studies testing ondansetron in Postoperative Nausea and Vomiting, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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).
Time frame: First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)
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.
Time frame: 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.
Time frame: Measured at 2, 6, 12, and 24 hours post-surgery
Number of Rescue Doses Required
Total number of rescue antiemetic (metoclopramide 10 mg IV) doses administered to each patient within the first 24 hours.
Time frame: First 24 hours after 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.
Time frame: At hospital discharge (approximately 24 hours post-surgery)
Adverse Events
Proportion of patients experiencing any adverse reaction including allergic reaction, headache, perineal burning, dystonia, or QT prolongation on post-operative ECG.
Time frame: From drug administration up to 24 hours post-surgery
Plan to share: No — Individual participant data will not be shared because the study is single-centre, small and unfunded. Only aggregated, de-identified, summary data will besshared
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
Of 67 non-industry phase 4 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 6 months is below that.
Counting every sponsor, half of 67 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ondansetron
Postoperative Nausea and Vomiting →