Akathisia in Post Operative Outpatients Surgery

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Completed

CT.gov ID

NCT01942343

Collaborator

(none)

300

Enrollment

Location

Arms

Actual Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Akathisia	Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 : Droperidol 1,25 mg	Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration
Active Comparator: Arm 2 : Droperidol 0,625 mg	Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration
Active Comparator: Arm 3 : Odansetron 4 mg	Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Arm

Intervention/Treatment

Active Comparator: Arm 1 : Droperidol 1,25 mg

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

Active Comparator: Arm 2 : Droperidol 0,625 mg

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

Active Comparator: Arm 3 : Odansetron 4 mg

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Les Hôpitaux Universitaires de Strasbourg	Strasbourg	Alsace	France	67000

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT01942343

Other Study ID Numbers:

5505

First Posted:

Sep 13, 2013

Last Update Posted:

Aug 27, 2018

Last Verified:

Aug 1, 2018

Additional relevant MeSH terms:

Psychomotor Agitation

Droperidol

Study Results

No Results Posted as of Aug 27, 2018