drugset / Trial / NCT02966041

Prophylactic Ondansetron in Post-op Cardiac Surgery Patients to Prevent Post-operative Nausea and Vomiting

NCT02966041 ↗

Completed 186 enrolled University of British Columbia
RandomizedParallel-groupQuadruple-blindPrevention

Summary

To evaluate the effectiveness of a prophylactic dose of ondansetron in decreasing the incidence of post-operative nausea and vomiting in cardiac surgery patients after cessation of post-operative sedation. In patients who have undergone open heart surgery, a single prophylactic dose of ondansetron 4 mg IV given at the time of discontinuing propofol sedation will result in a 50% reduction of the rate of post-operative nausea and vomiting in the first 24 post-operative hours compared to placebo.

Timeline

Start
2018-03-06
Primary completion
2018-07-11
Completion
2018-07-11

Outcome

Met primary endpoint

paper PONV within the first 24 hours postextubation occurred in 33 of 77 patients (43%) in the ondansetron group versus 50 PMID 32925337 ↗

paper absolute risk difference, -18% [95% CI, -33 to -2]; number needed to treat, 5.5 [95% CI, 3.0-58.4]; χ test, P = .022 PMID 32925337 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ondansetron Other / unclassified 4 mg Intravenous

Indications

No indication recorded.