Reassessment of Premedication in Surgery

Study Overview
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Brief Summary
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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
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Eligibility: 18 to 65 years old elective surgery in-hospital preoperative night Outcome measures: anxiety scales demographic data

Official Title
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Assessment of Two Modes of Premedication in Surgery - PREMED Study

Conditions
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Anxiety

Intervention / Treatment
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* Drug: Zopiclone
* Drug: Alprazolam
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zopiclone<br>zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery) | Drug: Zopiclone<br>* 7.5 mg before sleep, the evening before surgery<br>* Other names: Imovane;|
| Experimental: alprazolam<br>given at awakening, the day of surgery (placebo given before sleep, the day before surgery) | Drug: Alprazolam<br>* 0.5 mg at awakening, the day of surgery<br>* Other names: Xanax;|
| Placebo Comparator: placebo<br>Placebo given night before operation and the morning of operation | Drug: placebo<br>* given night before surgery and at awakening, the day of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety scales | * 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) | duration of the study : 12 hours (one evaluation on late afternoon the day before surgery and the second evaluation on arrival to operating room) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| markers of stress | recording of actual (using the operating room monitor): heart rate (at rest, supine) systolic blood pressure (at rest, supine) | on arrival to operating room (one single recording) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premedication, Benzodiazepine, Anti-anxiety agents, Anxiety, Surgery, Adult, Human