Reassessment of Premedication in Surgery

University Hospital, Angers455 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

455

Conditions

Anxiety

Interventions

ZopicloneDRUG

7.5 mg before sleep, the evening before surgery

AlprazolamDRUG

0.5 mg at awakening, the day of surgery

placeboDRUG

given night before surgery and at awakening, the day of surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (8)

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

Outcomes

Primary Outcomes

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)

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)

Secondary Outcomes

markers of stress

recording of actual (using the operating room monitor): * heart rate (at rest, supine) * systolic blood pressure (at rest, supine)

Time frame: on arrival to operating room (one single recording)

Data from ClinicalTrials.gov

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