DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Reassessment of Premedication in Surgery

Information source: University Hospital, Angers
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety

Intervention: Zopiclone (Drug); Alprazolam (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital, Angers

Official(s) and/or principal investigator(s):
Laurent Beydon, MD, Study Chair, Affiliation: University Hospital Angers (Dept of Anesthesia)

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

Clinical Details

Official title: Assessment of Two Modes of Premedication in Surgery - PREMED Study

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

Primary outcome: anxiety scales

Secondary outcome: markers of stress

Detailed description: Eligibility:

- 18 to 65 years old

- elective surgery

- in-hospital preoperative night

Outcome measures:

- anxiety scales

- demographic data

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Clinique Sévigné, Cesson, Bretagne 35576, France

Dept of Anesthesia, Hôpital Maison Blanche, Reims, Champagne 51092, France

Dept of Anesthesia, Hôpital Tenon, Paris, Ile de France 75020, France

Dept of Anesthesia, Hôpital Foch,, Suresnes, Ile de France 92150, France

Dept of Anesthesia, Le Mans, Maine 72000, France

Centre Paul Papin, Angers, Maine et Loire 49000, France

University Hospital, Angers, Maine et Loire 49933, France

Clinique St Leonard, Trélazé, Maine et Loire 49800, France

Additional Information

Starting date: March 2012
Last updated: September 24, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017