Akathisia in Post Operative Outpatients Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Akathisia

Intervention / Treatment
-----------------
* Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 : Droperidol 1,25 mg<br> | Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration<br> <br> |
| Active Comparator: Arm 2 : Droperidol 0,625 mg<br> | Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration<br> <br> |
| Active Comparator: Arm 3 : Odansetron 4 mg<br> | Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of akathisia | 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 | 1 day |