Reassessment of Premedication in Surgery (PREMED)

University Hospital, Angers

Status and phase: Completed; Phase 4

Conditions: Anxiety

Treatments: Drug: Zopiclone; Drug: Alprazolam; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01549691

PHRC 2011-20

2011-002553-65 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Eligibility:

• 18 to 65 years old
• elective surgery
• in-hospital preoperative night

Outcome measures:

• anxiety scales
• demographic data

Enrollment: 455 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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455 participants in 3 patient groups, including a placebo group

zopiclone

Experimental group

Description:

zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)

Treatment:

Drug: Zopiclone

alprazolam

Experimental group

Description:

given at awakening, the day of surgery (placebo given before sleep, the day before surgery)

Treatment:

Drug: Alprazolam

placebo

Placebo Comparator group

Description:

Placebo given night before operation and the morning of operation

Treatment:

Drug: placebo