drugset / Trial / NCT01942343

Akathisia in Post Operative Outpatients Surgery

NCT01942343

Phase 3 Completed 300 enrolled University Hospital, Strasbourg, France
RandomizedParallel-groupDouble-blindPrevention

Summary

The main objective of this study is to evaluate the incidence of akathisia with Droperidol, the prophylactic treatment of post operative nausea and vomiting, used at two different doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to compare the number of observed akathisia (Barnes score \> 1) in the Droperidol arms (0,625 mg and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO, that among patients taking Ondansetron.

Timeline

Start
2013-10
Primary completion
2015-10
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Droperidol Small molecule 0.625 mg
Comparator Droperidol Small molecule 1.25 mg
Comparator Ondansetron Other / unclassified 4 mg