Reassessment of Premedication in Surgery (PREMED)

September 24, 2013 updated by: University Hospital, Angers

Assessment of Two Modes of Premedication in Surgery - PREMED Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligibility:

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

Outcome measures:

  • anxiety scales
  • demographic data

Study Type

Interventional

Enrollment (Anticipated)

455

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bretagne
      • Cesson, Bretagne, France, 35576
        • Clinique Sévigné
    • Champagne
      • Reims, Champagne, France, 51092
        • Dept of Anesthesia, Hôpital Maison Blanche
    • Ile de France
      • Paris, Ile de France, France, 75020
        • Dept of Anesthesia, Hôpital Tenon
      • Suresnes, Ile de France, France, 92150
        • Dept of Anesthesia, Hôpital Foch,
    • Maine
      • Le Mans, Maine, France, 72000
        • Dept of anesthesia
    • Maine et Loire
      • Angers, Maine et Loire, France, 49000
        • Centre Paul Papin
      • Angers, Maine et Loire, France, 49933
        • University Hospital
      • Trélazé, Maine et Loire, France, 49800
        • Clinique St Leonard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
on arrival to operating room (one single recording)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

September 25, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 2011-20
  • 2011-002553-65 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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