Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
455 participants
INTERVENTIONAL
2012-03-31
2013-04-30
Brief Summary
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* 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
Detailed Description
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* 18 to 65 years old
* elective surgery
* in-hospital preoperative night
Outcome measures:
* anxiety scales
* demographic data
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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zopiclone
zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)
Zopiclone
7.5 mg before sleep, the evening before surgery
alprazolam
given at awakening, the day of surgery (placebo given before sleep, the day before surgery)
Alprazolam
0.5 mg at awakening, the day of surgery
placebo
Placebo given night before operation and the morning of operation
placebo
given night before surgery and at awakening, the day of surgery
Interventions
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Zopiclone
7.5 mg before sleep, the evening before surgery
Alprazolam
0.5 mg at awakening, the day of surgery
placebo
given night before surgery and at awakening, the day of surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* elective surgery
* in-hospital night before surgery
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Laurent Beydon, MD
Role: STUDY_CHAIR
University Hospital Angers (Dept of Anesthesia)
Locations
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Clinique Sévigné
Cesson, Brittany Region, France
Dept of Anesthesia, Hôpital Maison Blanche
Reims, Champagne, France
Centre Paul Papin
Angers, Maine et Loire, France
University Hospital
Angers, Maine et Loire, France
Clinique St Leonard
Trélazé, Maine et Loire, France
Dept of Anesthesia
Le Mans, Maine, France
Dept of Anesthesia, Hôpital Tenon
Paris, Île-de-France Region, France
Dept of Anesthesia, Hôpital Foch,
Suresnes, Île-de-France Region, France
Countries
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References
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Beydon L, Rouxel A, Camut N, Schinkel N, Malinovsky JM, Aveline C, Marret E, Bildea A, Dupoiron D, Liu N, Daniel V, Darsonval A, Chretien 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.
Other Identifiers
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2011-002553-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PHRC 2011-20
Identifier Type: -
Identifier Source: org_study_id