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Reassessment of Premedication in Surgery

NCT01549691 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2013-09-25

No results posted yet for this study

Summary

The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.

* one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery
* one receiving zopiclone (7.5 mg) before sleep and placebo at awakening
* one receiving placebo before sleep and alprazolam (0.5 mg)at awakening

double blind, randomized controlled study

Conditions

Interventions

DRUG

Zopiclone

7.5 mg before sleep, the evening before surgery

DRUG

Alprazolam

0.5 mg at awakening, the day of surgery

DRUG

placebo

given night before surgery and at awakening, the day of surgery

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Laurent Beydon, MD · University Hospital Angers (Dept of Anesthesia)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT01549691 on ClinicalTrials.gov