NCT01942343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

September 10, 2013

Last Update Submit

March 12, 2026

Conditions

Akathisia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Arm 1 : Droperidol 1,25 mg

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

Arm 2 : Droperidol 0,625 mg

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

Arm 3 : Odansetron 4 mg

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

Interventions

Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administrationDRUG
Arm 1 : Droperidol 1,25 mgArm 2 : Droperidol 0,625 mgArm 3 : Odansetron 4 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, 67000, France

Location

Related Publications (1)

  • 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.

    PMID: 29746373RESULT

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 16, 2026

Record last verified: 2026-01

Locations

FR(1)