Reassessment of Premedication in Surgery (PREMED)
This study is currently recruiting participants.
Verified December 2012 by University Hospital, Angers
Sponsor:
University Hospital, Angers
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
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety |
Drug: Zopiclone Drug: Alprazolam Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Assessment of Two Modes of Premedication in Surgery - PREMED Study |
Resource links provided by NLM:
Further study details as provided by University Hospital, Angers:
Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- 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)
| Estimated Enrollment: | 455 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: zopiclone
zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)
|
Drug: Zopiclone
7.5 mg before sleep, the evening before surgery
Other Name: Imovane
|
|
Experimental: alprazolam
given at awakening, the day of surgery (placebo given before sleep, the day before surgery)
|
Drug: Alprazolam
0.5 mg at awakening, the day of surgery
Other Name: Xanax
|
|
Placebo Comparator: placebo
Placebo given night before operation and the morning of operation
|
Drug: placebo
given night before surgery and at awakening, the day of surgery
Other Name: placebo
|
Detailed Description:
Eligibility:
- 18 to 65 years old
- elective surgery
- in-hospital preoperative night
Outcome measures:
- anxiety scales
- demographic data
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549691
Contacts
| Contact: Laurent Beydon, MD | 33 2 41 35 52 36 | lbeydon.angers@invivo.edu |
Locations
| France | |
| Clinique Sévigné | Recruiting |
| Cesson, Bretagne, France, 35576 | |
| Contact: Christophe Aveline, MD | |
| Principal Investigator: Christophe Aveline, MD | |
| Dept of Anesthesia, Hôpital Maison Blanche | Recruiting |
| Reims, Champagne, France, 51092 | |
| Contact: Jean Marc Malinvosky, MD | |
| Principal Investigator: Jean Marc Malinovsky, MD | |
| Dept of Anesthesia, Hôpital Tenon | Completed |
| Paris, Ile de France, France, 75020 | |
| Dept of Anesthesia, Hôpital Foch, | Completed |
| Suresnes, Ile de France, France, 92150 | |
| Centre Paul Papin | Recruiting |
| Angers, Maine et Loire, France, 49000 | |
| Contact: Denis Dupoiron, MD | |
| Principal Investigator: Denis Dupoiron, MD | |
| University Hospital | Recruiting |
| Angers, Maine et Loire, France, 49933 | |
| Contact: Laurent Beydon, MD | |
| Principal Investigator: Laurent Beydon, MD | |
| Sub-Investigator: Nathalie Houi, MD | |
| Clinique St Leonard | Completed |
| Trélazé, Maine et Loire, France, 49800 | |
| Dept of Anesthesia | Recruiting |
| Le Mans, Maine, France, 72000 | |
| Contact: Adriana Bildea, MD | |
| Principal Investigator: Adriana Bildea, MD | |
Sponsors and Collaborators
University Hospital, Angers
Investigators
| Study Chair: | Laurent Beydon, MD | University Hospital Angers (Dept of Anesthesia) |
More Information
No publications provided
| Responsible Party: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT01549691 History of Changes |
| Other Study ID Numbers: | PHRC 2011-20, 2011-002553-65 |
| Study First Received: | February 23, 2012 |
| Last Updated: | December 27, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Angers:
|
Premedication Benzodiazepine Anti-anxiety agents Anxiety |
Surgery Adult Human |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Alprazolam Zopiclone Anti-Anxiety Agents Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013