Akathisia in Post Operative Outpatients Surgery

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01942343

Enrollment

300

Registered

2013-09-13

Start date

2013-10-01

Completion date

2015-10-01

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Akathisia

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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026