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Akathisia in Post Operative Outpatients Surgery

NCT01942343 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Akathisia

Interventions

DRUG

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

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01942343 on ClinicalTrials.gov