Reassessment of Premedication in Surgery
Information source: University Hospital, Angers
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety
Intervention: Zopiclone (Drug); Alprazolam (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital, Angers Official(s) and/or principal investigator(s): Laurent Beydon, MD, Study Chair, Affiliation: University Hospital Angers (Dept of Anesthesia)
Summary
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
Clinical Details
Official title: Assessment of Two Modes of Premedication in Surgery - PREMED Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: anxiety scales
Secondary outcome: markers of stress
Detailed description:
Eligibility:
- 18 to 65 years old
- elective surgery
- in-hospital preoperative night
Outcome measures:
- anxiety scales
- demographic data
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Clinique Sévigné, Cesson, Bretagne 35576, France
Dept of Anesthesia, Hôpital Maison Blanche, Reims, Champagne 51092, France
Dept of Anesthesia, Hôpital Tenon, Paris, Ile de France 75020, France
Dept of Anesthesia, Hôpital Foch,, Suresnes, Ile de France 92150, France
Dept of Anesthesia, Le Mans, Maine 72000, France
Centre Paul Papin, Angers, Maine et Loire 49000, France
University Hospital, Angers, Maine et Loire 49933, France
Clinique St Leonard, Trélazé, Maine et Loire 49800, France
Additional Information
Starting date: March 2012
Last updated: September 24, 2013
|