Akathisia in Post Operative Outpatients Surgery

Phase 3

Completed

• Conditions: Akathisia
• Interventions: Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

• Registration Number: NCT01942343
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Study Start: 2013-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patient over 18 and under 65 year-old
• Having a moderate to severe POVN (post operative vomiting and nausea) risk, meaning with at least two risk factors in the simplified Apfel score
• Outpatient surgery associated to a general anesthesia
• Patient having signed an informed consent- Patient having a social protection

Exclusion Criteria

• Contraindication to Droperidol
• Contraindication to Ondansetron
• Patients usually treated with benzodiazepine or having been treated with benzodiazepine within 2 days prior to anesthesia
• Psychiatric and Neurodegenerative diseases
• Severe Anxiety
• Contraindication to general anesthesia or one of its components
• Allergy to propofol
• Inability to get informed (patient in an emergency situation, difficulties to understand)
• Patient under judicial protection
• Patient under tutorship or curatorship
• Pregnancy reported by the patient- Breastfeeding
• Patient in an exclusion period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3 : Odansetron 4 mg	Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration	-
Arm 1 : Droperidol 1,25 mg	Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration	-
Arm 2 : Droperidol 0,625 mg	Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration	-

Primary Outcome Measures

Name	Time	Method
Incidence of akathisia	1 day	The main objective of this study was to evaluate the incidence of akathisia with the waning of prophylactic treatment of PONV with droperidol used two different doses versus control group (ondansetron), ambulatory surgery

Trial Locations

Locations (1)

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, Alsace, France