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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

February 23, 2012
September 24, 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) ] [ 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)

Same as current
Complete list of historical versions of study NCT01549691 on ClinicalTrials.gov Archive Site
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)
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

Eligibility:

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

Outcome measures:

  • anxiety scales
  • demographic data
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anxiety
  • 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
    Other Name: placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
455
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01549691
PHRC 2011-20, 2011-002553-65
Yes
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