general anesthesia MedDRA version: 9.1 Level: LLT Classification code 10002323 Term: Anesthesia general
Conditions
Interventions
Trade Name: Bridion
Product Name: Bridion
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
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 under 18 years - Pregnancy, non menopausal woman - Allergy to propofol, soybeans or peanuts - Allergy to sufentanil, remifentanil, morphine, or to a component - Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl - Allergy to rocuronium or to bromure ion - History of a central neurological disorder or of a lesion cerebral - Patients receiving a psychotropic treatment - Presence of a pace-maker - Hypersensibility to sugammadex or to a component - Preoperative or immediate postoperative treatment with toremifene, flucloxacilline, or fusidic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are - efficacy of suggamadex, - clinical signs of recovery, - blood concentrations of propofol and remifentanil before and after suggamadex injection, - quality of the stay in the recovery room.;Primary end point(s): Increase in bispectral index following suggamadex injection;Main Objective: Main objective is to study bispectral index response to suggamadex injection while patients are still anesthetized. | — |
Countries
France
Outcome results
None listed