Akathisia in Post Operative Outpatients Surgery

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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Key information

Conditions

Akathisia Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

Incidence of akathisia

Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Sep 13, 2013
Registry last updated: Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed