Clinical trial NCT01549691: Reassessment of Premedication in Surgery
Official title: Assessment of Two Modes of Premedication in Surgery - PREMED Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety
Keywords: Premedication
Benzodiazepine
Anti-anxiety agents
Anxiety
Surgery
Adult
Human
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2012-03-09
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: anxiety scales
timeFrame: 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:
measure: markers of stress
timeFrame: on arrival to operating room (one single recording)
Other outcomes:
Locations:
city: Cesson
country: France
facility: Clinique Sévigné
state: Bretagne
city: Reims
country: France
facility: Dept of Anesthesia, Hôpital Maison Blanche
state: Champagne
city: Paris
country: France
facility: Dept of Anesthesia, Hôpital Tenon
state: Ile de France
city: Suresnes
country: France
facility: Dept of Anesthesia, Hôpital Foch,
state: Ile de France
city: Angers
country: France
facility: Centre Paul Papin
state: Maine et Loire
city: Angers
country: France
facility: University Hospital
state: Maine et Loire
city: Trélazé
country: France
facility: Clinique St Leonard
state: Maine et Loire
city: Le Mans
country: France
facility: Dept of Anesthesia
state: Maine
Study officials:
affiliation: University Hospital Angers (Dept of Anesthesia)
name: Laurent Beydon, MD
role: STUDY_CHAIR
References:
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.