Reassessment of Premedication in Surgery (PREMED)

This study is currently recruiting participants.

Verified December 2012 by University Hospital, Angers

Sponsor:

Information provided by (Responsible Party):

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT01549691

First received: February 23, 2012

Last updated: December 27, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2012

Last Updated Date

December 27, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

anxiety scales [ 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) ] [ Designated as safety issue: No ]

* 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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01549691 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

markers of stress [ Time Frame: on arrival to operating room (one single recording) ] [ Designated as safety issue: No ]

recording of actual (using the operating room monitor):

heart rate (at rest, supine)
systolic blood pressure (at rest, supine)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Reassessment of Premedication in Surgery

Official Title ^ICMJE

Assessment of Two Modes of Premedication in Surgery - PREMED Study

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Anxiety

Intervention ^ICMJE

Drug: Zopiclone
7.5 mg before sleep, the evening before surgery

Other Name: Imovane
Drug: Alprazolam
0.5 mg at awakening, the day of surgery

Other Name: Xanax
Drug: placebo
given night before surgery and at awakening, the day of surgery

Other Name: placebo

Study Arm (s)

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

Intervention: Drug: Zopiclone
Experimental: alprazolam
given at awakening, the day of surgery (placebo given before sleep, the day before surgery)

Intervention: Drug: Alprazolam
Placebo Comparator: placebo
Placebo given night before operation and the morning of operation

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

455

Estimated Completion Date

May 2013

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Laurent Beydon, MD

33 2 41 35 52 36

lbeydon.angers@invivo.edu

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01549691

Other Study ID Numbers ^ICMJE

PHRC 2011-20, 2011-002553-65

Has Data Monitoring Committee

Yes

Responsible Party

University Hospital, Angers

Study Sponsor ^ICMJE

University Hospital, Angers

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Laurent Beydon, MD

University Hospital Angers (Dept of Anesthesia)

Information Provided By

University Hospital, Angers

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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