NCT01549691

Reassessment of Premedication in Surgery

Assessment of Two Modes of Premedication in Surgery - PREMED Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 455 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Anxiety

Interventions

Type	Name	Description
DRUG	Zopiclone	7.5 mg before sleep, the evening before surgery
DRUG	Alprazolam	0.5 mg at awakening, the day of surgery
DRUG	placebo	given night before surgery and at awakening, the day of surgery

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-03-09
• Last updated: 2013-09-25

Locations

8 sites across 1 country: France