Assessment of Two Modes of Premedication in Surgery - PREMED Study
Overview
- Phase
- Phase 4
- Intervention
- Zopiclone
- Conditions
- Anxiety
- Sponsor
- University Hospital, Angers
- Enrollment
- 455
- Locations
- 8
- Primary Endpoint
- anxiety scales
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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
Detailed Description
Eligibility: * 18 to 65 years old * elective surgery * in-hospital preoperative night Outcome measures: * anxiety scales * demographic data
Investigators
Eligibility 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
Arms & Interventions
zopiclone
zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)
Intervention: Zopiclone
alprazolam
given at awakening, the day of surgery (placebo given before sleep, the day before surgery)
Intervention: Alprazolam
placebo
Placebo given night before operation and the morning of operation
Intervention: placebo
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- markers of stress(on arrival to operating room (one single recording))