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Reassessment of Premedication in Surgery (PREMED)

Primary Purpose

Anxiety

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Zopiclone
Alprazolam
placebo
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Premedication, Benzodiazepine, Anti-anxiety agents, Anxiety, Surgery, Adult, Human

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinique Sévigné
  • Dept of Anesthesia, Hôpital Maison Blanche
  • Dept of Anesthesia, Hôpital Tenon
  • Dept of Anesthesia, Hôpital Foch,
  • Centre Paul Papin
  • University Hospital
  • Clinique St Leonard
  • Dept of Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

zopiclone

alprazolam

placebo

Arm Description

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

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

Placebo given night before operation and the morning of operation

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

markers of stress
recording of actual (using the operating room monitor): heart rate (at rest, supine) systolic blood pressure (at rest, supine)

Full Information

First Posted
February 23, 2012
Last Updated
September 24, 2013
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01549691
Brief Title
Reassessment of Premedication in Surgery
Acronym
PREMED
Official Title
Assessment of Two Modes of Premedication in Surgery - PREMED Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Premedication, Benzodiazepine, Anti-anxiety agents, Anxiety, Surgery, Adult, Human

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
455 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
zopiclone
Arm Type
Experimental
Arm Description
zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)
Arm Title
alprazolam
Arm Type
Experimental
Arm Description
given at awakening, the day of surgery (placebo given before sleep, the day before surgery)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given night before operation and the morning of operation
Intervention Type
Drug
Intervention Name(s)
Zopiclone
Other Intervention Name(s)
Imovane
Intervention Description
7.5 mg before sleep, the evening before surgery
Intervention Type
Drug
Intervention Name(s)
Alprazolam
Other Intervention Name(s)
Xanax
Intervention Description
0.5 mg at awakening, the day of surgery
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
given night before surgery and at awakening, the day of surgery
Primary Outcome Measure Information:
Title
anxiety scales
Description
* 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)
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)
Secondary Outcome Measure Information:
Title
markers of stress
Description
recording of actual (using the operating room monitor): heart rate (at rest, supine) systolic blood pressure (at rest, supine)
Time Frame
on arrival to operating room (one single recording)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Beydon, MD
Organizational Affiliation
University Hospital Angers (Dept of Anesthesia)
Official's Role
Study Chair
Facility Information:
Facility Name
Clinique Sévigné
City
Cesson
State/Province
Bretagne
ZIP/Postal Code
35576
Country
France
Facility Name
Dept of Anesthesia, Hôpital Maison Blanche
City
Reims
State/Province
Champagne
ZIP/Postal Code
51092
Country
France
Facility Name
Dept of Anesthesia, Hôpital Tenon
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75020
Country
France
Facility Name
Dept of Anesthesia, Hôpital Foch,
City
Suresnes
State/Province
Ile de France
ZIP/Postal Code
92150
Country
France
Facility Name
Centre Paul Papin
City
Angers
State/Province
Maine et Loire
ZIP/Postal Code
49000
Country
France
Facility Name
University Hospital
City
Angers
State/Province
Maine et Loire
ZIP/Postal Code
49933
Country
France
Facility Name
Clinique St Leonard
City
Trélazé
State/Province
Maine et Loire
ZIP/Postal Code
49800
Country
France
Facility Name
Dept of Anesthesia
City
Le Mans
State/Province
Maine
ZIP/Postal Code
72000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26004882
Citation
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.
Results Reference
derived

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Reassessment of Premedication in Surgery

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