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Akathisia in Post Operative Outpatients Surgery

Primary Purpose

Akathisia

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Akathisia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Les Hôpitaux Universitaires de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm 1 : Droperidol 1,25 mg

Arm 2 : Droperidol 0,625 mg

Arm 3 : Odansetron 4 mg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01942343

First Posted

September 10, 2013

Last Updated

August 24, 2018

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT01942343

Brief Title

Akathisia in Post Operative Outpatients Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

October 2013 (Actual)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Akathisia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 : Droperidol 1,25 mg

Arm Type

Active Comparator

Arm Title

Arm 2 : Droperidol 0,625 mg

Arm Type

Active Comparator

Arm Title

Arm 3 : Odansetron 4 mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Incidence of akathisia

Description

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Les Hôpitaux Universitaires de Strasbourg

City

Strasbourg

State/Province

Alsace

ZIP/Postal Code

67000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

29746373

Citation

Charton A, Greib N, Ruimy A, Faitot V, Noudem Y, Joshi GP, Meyer N, Diemunsch P. Incidence of akathisia after postoperative nausea and vomiting prophylaxis with droperidol and ondansetron in outpatient surgery: A multicentre controlled randomised trial. Eur J Anaesthesiol. 2018 Dec;35(12):966-971. doi: 10.1097/EJA.0000000000000821.

Results Reference

derived

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Akathisia in Post Operative Outpatients Surgery

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