Akathisia in Post Operative Outpatients Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Akathisia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1 : Droperidol 1,25 mg

Group Type ACTIVE_COMPARATOR

Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Intervention Type DRUG

Arm 2 : Droperidol 0,625 mg

Group Type ACTIVE_COMPARATOR

Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Intervention Type DRUG

Arm 3 : Odansetron 4 mg

Group Type ACTIVE_COMPARATOR

Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Intervention Type DRUG

Interventions

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Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No