Akathisia in Post Operative Outpatients Surgery

Akathisia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942343
• Other study ID #: 5505
• Status: Completed
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: August 2018
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Akathisia
• Psychomotor Agitation

Intervention

Drug:
• Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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