Impact des facteurs chronologiques et démographiques sur les posologies per-opératoires des agents anesthésiques (Etude prospective multicentrique) - PosoAnes
- Conditions
- general anesthesiaMedDRA version: 9.1Level: LLTClassification code 10002323Term: Anesthesia general
- Registration Number
- EUCTR2008-008193-31-FR
- Lead Sponsor
- Hopital Foch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 4500
Patients scheduled for general anesthesia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- age lower than 18 years,
- pregnancy, nursing women
- combination of general anesthesia and loco-regional anesthesia,
- allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,
- patients receiving a psychotropic treatment, and patients taking agonist-antagonist opiates,
- presence of a central neurological disorder or a lesion cerebral,
- history of hypersensibility to remifentanil or to a derivate of fentanyl,
- presence of a pace-maker,
- surgery on the skull or operating position preventing the use of bispectral index sensor in suitable conditions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Main objective is to study infuence of the season, the hour, the gender, the cycle time and the age on propofol doses required to maintain the bispectral index between 40 and 60 during the maintenance of anesthesia.;Secondary Objective: Secondary objectives are remifentanil doses, time to wake up, and intraoperative awareness;Primary end point(s): Comparaison of propofol doses by season, hour, gender, cycle time and age
- Secondary Outcome Measures
Name Time Method