Akathisia in Post Operative Outpatients Surgery

Phase 3CompletedNCT01942343

University Hospital, Strasbourg, France300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

300

Conditions

Akathisia

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, France

Outcomes

Primary Outcomes

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

Time frame: 1 day

Data from ClinicalTrials.gov

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