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PREMED: Reassessment of Premedication in Surgery

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT01549691
Collaborator
(none)
455
Enrollment
8
Locations
3
Arms
13
Duration (Months)
56.9
Patients Per Site
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Eligibility:

  • 18 to 65 years old

  • elective surgery

  • in-hospital preoperative night

Outcome measures:

  • anxiety scales

  • demographic data

Study Design

Study Type:
Interventional
Anticipated Enrollment :
455 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Assessment of Two Modes of Premedication in Surgery - PREMED Study
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: zopiclone

zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)

Drug: Zopiclone
7.5 mg before sleep, the evening before surgery
Other Names:
  • Imovane

    		•
    Experimental: alprazolam

    given at awakening, the day of surgery (placebo given before sleep, the day before surgery)

    Drug: Alprazolam
    0.5 mg at awakening, the day of surgery
    Other Names:
  • Xanax

    		•
    Placebo Comparator: placebo

    Placebo given night before operation and the morning of operation

    Drug: placebo
    given night before surgery and at awakening, the day of surgery

    Outcome Measures

    Primary Outcome Measures

    1. anxiety scales [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 Outcome Measures

    1. markers of stress [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Sévigné Cesson Bretagne France 35576
    2 Dept of Anesthesia, Hôpital Maison Blanche Reims Champagne France 51092
    3 Dept of Anesthesia, Hôpital Tenon Paris Ile de France France 75020
    4 Dept of Anesthesia, Hôpital Foch, Suresnes Ile de France France 92150
    5 Centre Paul Papin Angers Maine et Loire France 49000
    6 University Hospital Angers Maine et Loire France 49933
    7 Clinique St Leonard Trélazé Maine et Loire France 49800
    8 Dept of Anesthesia Le Mans Maine France 72000

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

    • Study Chair: Laurent Beydon, MD, University Hospital Angers (Dept of Anesthesia)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT01549691
    Other Study ID Numbers:
    • PHRC 2011-20
    • 2011-002553-65
    First Posted:
    Mar 9, 2012
    Last Update Posted:
    Sep 25, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by University Hospital, Angers
    Premedication
    Benzodiazepine
    Anti-anxiety agents
    Anxiety
    Surgery
    Adult
    Human
    Additional relevant MeSH terms:
    Anxiety Disorders
    Alprazolam
    Zopiclone

    Study Results

    No Results Posted as of Sep 25, 2013