Skip to main content
OpenTrials
Completed

NCT Number: NCT01549691

Reassessment of Premedication in Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinique Sévigné, Cesson, Brittany Region, France

Loading trial locations.

About this study

Eligibility:

  • 18 to 65 years old
  • elective surgery
  • in-hospital preoperative night

Outcome measures:

  • anxiety scales
  • demographic data

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-65 years old
  • elective surgery
  • in-hospital night before surgery

Exclusion criteria

  • myasthenia gravis
  • chronic intake of psychotropic drugs
  • opiates intake
  • severe obstructive sleep apnea
  • intracranial hypertension
  • morbid obesity
  • myasthenia gravis
  • acute severe medical disorder
  • non health insurance coverage
  • protected patients by law
  • pregnancy
  • non French speaking

Treatment and study plan

Zopiclone

Drug

7.5 mg before sleep, the evening before surgery

Other names: Imovane

alprazolam

Drug

0.5 mg at awakening, the day of surgery

Other names: Xanax

Placebo

Drug

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

Primary outcomes

  1. anxiety scales

    Time frame: duration of the study : 12 hours (one evaluation on late afternoon the day before surgery and the second evaluation on arrival to operating room)

    • The day before surgery (late afternoon) : patient's self rating of anxiety and desire of information regarding upcoming surgery (Amsterdam patient anxiety and information scale, APAIS)
    • On arrival to the operating room : Recording of the level of declared anxiety (numeric scale similar to that corresponding of the "anxiety component of the APAIS scale)

Secondary outcomes

  1. markers of stress

    Time frame: on arrival to operating room (one single recording)

    recording of actual (using the operating room monitor):

    • heart rate (at rest, supine)
    • systolic blood pressure (at rest, supine)

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Assessment of Two Modes of Premedication in Surgery - PREMED Study

Acronym: PREMED

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 9, 2012
Registry last updated
Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.