Reassessment of Premedication in Surgery (PREMED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01549691
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : September 25, 2013
Information provided by (Responsible Party):
University Hospital, Angers

February 23, 2012
March 9, 2012
September 25, 2013
March 2012
April 2013   (Final data collection date for primary outcome measure)
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)

Same as current
Complete list of historical versions of study NCT01549691 on Archive Site
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)
Same as current
Not Provided
Not Provided
Reassessment of Premedication in Surgery
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


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

Outcome measures:

  • anxiety scales
  • demographic data
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Zopiclone
    7.5 mg before sleep, the evening before surgery
    Other Name: Imovane
  • Drug: Alprazolam
    0.5 mg at awakening, the day of surgery
    Other Name: Xanax
  • Drug: placebo
    given night before surgery and at awakening, the day of surgery
  • Experimental: zopiclone
    zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)
    Intervention: Drug: Zopiclone
  • Experimental: alprazolam
    given at awakening, the day of surgery (placebo given before sleep, the day before surgery)
    Intervention: Drug: Alprazolam
  • Placebo Comparator: placebo
    Placebo given night before operation and the morning of operation
    Intervention: Drug: placebo
Beydon L, Rouxel A, Camut N, Schinkel N, Malinovsky JM, Aveline C, Marret E, Bildea A, Dupoiron D, Liu N, Daniel V, Darsonval A, Chrétien JM, Rault L, Bruna J, Alberti C. Sedative premedication before surgery--A multicentre randomized study versus placebo. Anaesth Crit Care Pain Med. 2015 Jun;34(3):165-71. doi: 10.1016/j.accpm.2015.01.005. Epub 2015 May 23.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
PHRC 2011-20
2011-002553-65 ( EudraCT Number )
Not Provided
Not Provided
University Hospital, Angers
University Hospital, Angers
Not Provided
Study Chair: Laurent Beydon, MD University Hospital Angers (Dept of Anesthesia)
University Hospital, Angers
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP