Postoperative Nausea and VomitingPhase 4NCT07638527
Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy
A Phase 4 study testing ondansetron 4 mg, Dexamethasone (intravenous) and Metoclopramide 10mg in people with Postoperative Nausea and Vomiting, run by Faisalabad Medical University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- ondansetron 4 mg, Dexamethasone (intravenous) and Metoclopramide 10mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2026to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Faisalabad Medical University
Faisalābad, Punjab Province, 38000
Asifa Saeed, MBBS; FCPS, +923006694460, drasifasaeed@gmail.com
Huda Ather, MBBS, +923047922909, atherhudaather@gmail.com
About this study
Official 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
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:
Read more
- 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
- Being tested
- ondansetron 4 mg, Dexamethasone (intravenous), Metoclopramide 10mg
- Keywords
- PONV, Postoperative emesis, Postoperative nausea, Postoperative vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetron 4 mgDrug
Also called Zofran, Zophren, Onmax
Ondansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
Dexamethasone (intravenous)Drug
Also called Decadron, Oradexon, Fortecortin
Dexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
Metoclopramide 10mgDrug
Also called Maxolon, Reglan, Paspertin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexamethasone (intravenous); Drug: Metoclopramide 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)
Secondary outcomes (4)
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.
Measured: 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: 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.
Measured: 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.
Measured: At hospital discharge (approximately 24 hours post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faisalabad Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Asifa Saeed, Faisalabad Medical University
- Investigators
- Asifa Saeed, MBBS; FCPS, Principal investigator, Faisalabad Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638527
- Sponsor's protocol ID
- 48/ERC/FMU/2025-26/343
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
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.
PubMed 25629760Naguib 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.
PubMed 8829860Chattopadhyay 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.
Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.
PubMed 22263004Korkusuz 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.
PubMed 41178893Si 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.
PubMed 24942194Mishriky 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.
PubMed 22307240Ko-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.
PubMed 25920297Gan 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.
PubMed 41237407Apfel 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.
PubMed 10485781Weibel 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.
PubMed 33075160
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07638527
- Acronym / sponsor ID
- 48/ERC/FMU/2025-26/343
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- PONV, Postoperative emesis, Postoperative nausea, Postoperative vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Faisalabad Medical UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Ondansetron and Metoclopramide)- Separate syringes | Experimental | Drug: ondansetron 4 mg, Drug: Metoclopramide 10mgParticipants receive * Ondansetron (4 mg IV) and * Metoclopramide (10 mg IV), in two separate colorless syringes, 5-10 minutes before the induction of general anesthesia. |
| Group B (Dexamethasone and Metoclopramide)- Separate syringes | Active comparator | Drug: Dexamethasone (intravenous), Drug: Metoclopramide 10mgParticipants receive * Dexamethasone 8mg IV and * Metoclopramide 10mg IV, in two separate colorless syringes, 5-10 minutes before the induction of general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ondansetron 4 mgAlso: Zofran, Zophren, OnmaxOndansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting. | Drug | Group A (Ondansetron and Metoclopramide)- Separate syringes |
| Dexamethasone (intravenous)Also: Decadron, Oradexon, FortecortinDexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting. | Drug | Group B (Dexamethasone and Metoclopramide)- Separate syringes |
| Metoclopramide 10mgAlso: Maxolon, Reglan, PaspertinMetoclopramide 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. | Drug | Group A (Ondansetron and Metoclopramide)- Separate syringes, Group B (Dexamethasone and Metoclopramide)- Separate syringes |
Primary outcome
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).
4 secondary outcomes
Incidence of PONV
Time frame: 24 hours post-surgery
Severity of Postoperative Nausea and Vomiting (RINVR Score)
Time frame: Measured at 2, 6, 12, and 24 hours post-surgery
Number of Rescue Doses Required
Time frame: First 24 hours after surgery
Patient Satisfaction with Antiemetic Treatment
Time frame: At hospital discharge (approximately 24 hours post-surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- BackgroundAlam, 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: PubMed 25629760Abel 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.
- Background: PubMed 8829860Naguib 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.
- BackgroundChattopadhyay 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: PubMed 22263004Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.
- Background: PubMed 41178893Korkusuz 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.
- Background: PubMed 24942194Si 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.
- Background: PubMed 22307240Mishriky 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.
- Background: PubMed 25920297Ko-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.
- Background: PubMed 41237407Gan 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.
- Background: PubMed 10485781Apfel 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.
- Background: PubMed 33075160Weibel 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.
- 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 RLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asifa Saeed, MBBS; FCPS principal investigator
Faisalabad Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ondansetron 4 mg, Dexamethasone (intravenous) and Metoclopramide 10mg in people with Postoperative Nausea and Vomiting, run by Faisalabad Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asifa Saeed, MBBS; FCPS (+923006694460, drasifasaeed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07638527, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.