Reassessment of Premedication in Surgery (PREMED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01549691
First received: February 23, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Anxiety
Drug: Zopiclone
Drug: Alprazolam
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Two Modes of Premedication in Surgery - PREMED Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    * 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:
  • markers of stress [ Time Frame: on arrival to operating room (one single recording) ] [ Designated as safety issue: No ]

    recording of actual (using the operating room monitor):

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


Estimated Enrollment: 455
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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
Other Name: placebo

Detailed Description:

Eligibility:

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

Outcome measures:

  • anxiety scales
  • demographic data
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549691

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

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01549691     History of Changes
Other Study ID Numbers: PHRC 2011-20, 2011-002553-65
Study First Received: February 23, 2012
Last Updated: September 24, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Angers:
Premedication
Benzodiazepine
Anti-anxiety agents
Anxiety
Surgery
Adult
Human

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Alprazolam
Zopiclone
Anti-Anxiety Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014