NCT01942343

Akathisia in Post Operative Outpatients Surgery

Etude de l'Effet du dropéridol et de l'Ondansetron Sur l'Incidence de l'Akathisie Post opératoire en Chirurgie Ambulatoire

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Akathisia

Interventions

Type	Name	Description
DRUG	Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-09-13
• Last updated: 2026-03-16

Locations

1 site across 1 country: France