Phase 4
N=141
Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting
Post-operative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT03297021 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Nausea Scale — 3.5; 4.0; 4.0; 2.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ondansetron 4 MG (Drug); Ondansetron 8mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nausea Scale |
3.5; 4.0; 4.0; 2.0; 1.0; 8.0 | — |
| SECONDARY Number of Participants With Episodes of Vomiting in the PACU |
2; 0; 1 | — |
| SECONDARY Number of Participants With Symptoms on POD 1 |
9; 4; 1; 1; 1; 0 | — |
| SECONDARY Number of Participants Who Needed Rescue Anti-emetics |
4; 1; 2 | — |
| SECONDARY Total Anesthesia Time |
116.0; 128.5; 118.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia
Exclusion Criteria
- Patients with allergies or contraindications to study medications
Data sourced from ClinicalTrials.gov (NCT03297021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.