Akathisia in Post Operative Outpatients Surgery

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Droperidol

Criteria

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