Reassessment of Premedication in Surgery

Phase 4

Completed

• Conditions: Anxiety
• Interventions: Drug: placebo; Drug: Alprazolam; Drug: Zopiclone

• Registration Number: NCT01549691
• Lead Sponsor: University Hospital, Angers

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

Study Timeline

• Study First Submitted: 2012-02-23
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-09
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 455

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Placebo given night before operation and the morning of operation
alprazolam	Alprazolam	given at awakening, the day of surgery (placebo given before sleep, the day before surgery)
zopiclone	Zopiclone	zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)

Primary Outcome Measures

Name	Time	Method
anxiety scales	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 Outcome Measures

Name	Time	Method
markers of stress	on arrival to operating room (one single recording)	recording of actual (using the operating room monitor): * heart rate (at rest, supine); * systolic blood pressure (at rest, supine)

Trial Locations

Locations (8)

Dept of Anesthesia, Hôpital Foch,; 🇫🇷 Suresnes, Ile de France, France

Dept of Anesthesia, Hôpital Tenon; 🇫🇷 Paris, Ile de France, France

Clinique St Leonard; 🇫🇷 Trélazé, Maine et Loire, France

Clinique Sévigné; 🇫🇷 Cesson, Bretagne, France

University Hospital; 🇫🇷 Angers, Maine et Loire, France

Dept of Anesthesia; 🇫🇷 Le Mans, Maine, France

Dept of Anesthesia, Hôpital Maison Blanche; 🇫🇷 Reims, Champagne, France

Centre Paul Papin; 🇫🇷 Angers, Maine et Loire, France