NCT03297021 is a Phase 4 clinical trial of Ondansetron 4 MG in Post-operative Nausea and Vomiting, sponsored by Icahn School of Medicine at Mount Sinai.

Who is sponsoring NCT03297021?

NCT03297021 is sponsored by Icahn School of Medicine at Mount Sinai.

What drugs are being tested in NCT03297021?

Interventions in NCT03297021: Ondansetron 4 MG, Ondansetron 8mg.

What condition does NCT03297021 study?

NCT03297021 studies Post-operative Nausea and Vomiting.

Is NCT03297021 still recruiting?

NCT03297021 is currently completed. Last updated 20 July 2020.

Are results published for NCT03297021?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-07-20 · How we verify

NCT03297021

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting

Completed Phase 4 Results posted Last updated 20 July 2020

What this trial tests

Phase 4 trial testing Ondansetron 4 MG in Post-operative Nausea and Vomiting in 141 participants. Completed in 5 April 2019.

Timeline

23 October 2017

Primary endpoint
5 April 2019

5 April 2019

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	prevention
Enrollment	141
Start date	23 October 2017
Primary completion	5 April 2019
Estimated completion	5 April 2019
Sites	1 location across United States

Drugs / interventions tested

Ondansetron 4 MG — full drug profile →
Ondansetron 8mg — full drug profile →

Conditions studied

Post-operative Nausea and Vomiting — all drugs for Post-operative Nausea and Vomiting →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Post-operative Nausea and Vomiting. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Nausea Scale Primary · average of 4 hours in PACU and POD1

Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea

PACU

Group	Value	95% CI
Ondansetron 4mg Pre-emergence	3.5	1.75 – 4.0
Ondansetron 8mg Pre-emergence	4.0	3.0 – 6.0
Ondansetron Pre-Incision and Pre-emergence	4.0	1.5 – 6.0

POD1

Group	Value	95% CI
Ondansetron 4mg Pre-emergence	2.0	1.0 – 3.0
Ondansetron 8mg Pre-emergence	1.0	1.0 – 5.5
Ondansetron Pre-Incision and Pre-emergence	8.0	8.0 – 8.0

Number of Participants With Episodes of Vomiting in the PACU Secondary · average of 4 hours

Number of participants with episodes of vomiting in the Post Anesthesia Care Unit

Group	Value	95% CI
Ondansetron 4mg Pre-emergence	2
Ondansetron 8mg Pre-emergence	0
Ondansetron Pre-Incision and Pre-emergence	1

Number of Participants With Symptoms on POD 1 Secondary · Day 1

Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one

Nausea

Group	Value	95% CI
Ondansetron 4mg Pre-emergence	9
Ondansetron 8mg Pre-emergence	4
Ondansetron Pre-Incision and Pre-emergence	1

Vomiting

Group	Value	95% CI
Ondansetron 4mg Pre-emergence	1
Ondansetron 8mg Pre-emergence	1
Ondansetron Pre-Incision and Pre-emergence	0

Headache

Group	Value	95% CI
Ondansetron 4mg Pre-emergence	5
Ondansetron 8mg Pre-emergence	5
Ondansetron Pre-Incision and Pre-emergence	3

Number of Participants Who Needed Rescue Anti-emetics Secondary · average of 4 hours

Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU

Group	Value	95% CI
Ondansetron 4mg Pre-emergence	4
Ondansetron 8mg Pre-emergence	1
Ondansetron Pre-Incision and Pre-emergence	2

Total Anesthesia Time Secondary · intraoperative, up to 3.5 hours

Group	Value	95% CI
Ondansetron 4mg Pre-emergence	116.0	93.0 – 178.0
Ondansetron 8mg Pre-emergence	128.5	86.5 – 186.25
Ondansetron Pre-Incision and Pre-emergence	118.0	93.0 – 172.0

Sponsor's own description

The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.
Weibel S, Rücker G, Eberhart LH, Pace NL, et al · · 2020 · cited 125× · PMID 33075160 · DOI 10.1002/14651858.cd012859.pub2

Verify or expand the search:

Other trials of Ondansetron 4 MG

Trials testing the same drug.

NCT04606264 — Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data · Phase 3 · completed
NCT05221151 — Melatonin vs Pregabalin for Anxiolysis and Sedation · Phase 4 · completed
NCT05127876 — Ephedrine Versus Ondansetron During Cesarean Delivery · Phase 4 · completed
NCT04318847 — Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting · Phase 4 · unknown
NCT04983498 — Enhanced Recovery Pathway for Endoscopy · Phase 4 · withdrawn

Other Icahn School of Medicine at Mount Sinai trials

Trials by the same sponsor.

NCT07094308 — The LIFT-ECHO Last Mile Project · NA · not yet recruiting
NCT07291427 — Chronic Subdural Hematoma Embolization With Detachable Coils · not yet recruiting
NCT07194187 — High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction · NA · not yet recruiting
NCT07260916 — Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation · NA · not yet recruiting
NCT07487948 — Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03297021 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
Last refreshed: 20 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03297021.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing