general anesthesia MedDRA version: 9.1 Level: LLT Classification code 10002323 Term: Anesthesia general
Conditions
Interventions
Trade Name: Ultiva
Product Name: Ultiva
Pharmaceutical Form: Powder for infusion*
Trade Name: Propofol
Product Name: Propofol
Pharmaceutical Form: Intravenous infusion
Sponsors
Hopital Foch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Outcome results
None listed