NCT01549691

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
455

participants targeted

Target at P75+ for phase_4 anxiety

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

September 25, 2013

Status Verified

September 1, 2013

Enrollment Period

1.1 years

First QC Date

February 23, 2012

Last Update Submit

September 24, 2013

Conditions

Anxiety

Keywords

PremedicationBenzodiazepineAnti-anxiety agentsAnxietySurgeryAdultHuman

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • markers of stress

    on arrival to operating room (one single recording)

Study Arms (3)

zopiclone

EXPERIMENTAL

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

Drug: Zopiclone

alprazolam

EXPERIMENTAL

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

Drug: Alprazolam

placebo

PLACEBO COMPARATOR

Placebo given night before operation and the morning of operation

Drug: placebo

Interventions

ZopicloneDRUG

7.5 mg before sleep, the evening before surgery

Also known as: Imovane
zopiclone
AlprazolamDRUG

0.5 mg at awakening, the day of surgery

Also known as: Xanax
alprazolam
placeboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-65 years old
  • elective surgery
  • in-hospital night before surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Clinique Sévigné

Cesson, Brittany Region, 35576, France

Location

Dept of Anesthesia, Hôpital Maison Blanche

Reims, Champagne, 51092, France

Location

Centre Paul Papin

Angers, Maine et Loire, 49000, France

Location

University Hospital

Angers, Maine et Loire, 49933, France

Location

Clinique St Leonard

Trélazé, Maine et Loire, 49800, France

Location

Dept of Anesthesia

Le Mans, Maine, 72000, France

Location

Dept of Anesthesia, Hôpital Tenon

Paris, Île-de-France Region, 75020, France

Location

Dept of Anesthesia, Hôpital Foch,

Suresnes, Île-de-France Region, 92150, France

Location

Related Publications (1)

  • Beydon L, Rouxel A, Camut N, Schinkel N, Malinovsky JM, Aveline C, Marret E, Bildea A, Dupoiron D, Liu N, Daniel V, Darsonval A, Chretien JM, Rault L, Bruna J, Alberti C. Sedative premedication before surgery--A multicentre randomized study versus placebo. Anaesth Crit Care Pain Med. 2015 Jun;34(3):165-71. doi: 10.1016/j.accpm.2015.01.005. Epub 2015 May 23.

    PMID: 26004882DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

zopicloneAlprazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Laurent Beydon, MD

    University Hospital Angers (Dept of Anesthesia)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2012

First Posted

March 9, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 25, 2013

Record last verified: 2013-09

Locations

FR(8)