drugset / Trial / NCT00757822

Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients

NCT00757822 ↗

Completed 216 enrolled VA Office of Research and Development
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will compare two different drug regimens (oral dronabinol versus intravenous ondanseteron) for the prevention of post-operative nausea and vomiting (PONV).

Timeline

Start
2009-12
Primary completion
2013-12
Completion
2015-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Arm 1:Dronabinol vs Arm 2:Ondansetron; p >0.76; Difference in Percentages 4.6 (90% CI -9.5 to 18.6); Fisher Exact NCT00757822 ↗

registry analysis (superiority or other test); Arm 1: Dronabinol vs Arm 2:Ondansetron; p >0.92; Fisher Exact NCT00757822 ↗

registry analysis (superiority or other test); Arm 1: Dronabinol vs Arm 2:Ondansetron; p >0.55; Difference in Percentages 7.7 (90% CI -12.1 to 13.3); Fisher Exact NCT00757822 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dronabinol Other / unclassified 5 mg Oral
Comparator Ondansetron Other / unclassified 4 mg Intravenous

Indications

No indication recorded.