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
Trade Name: Mivacron
Product N
Sponsors
Hopital Foch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients scheduled - for general anesthesia including the administration of a myorelaxant to facilitate tracheal intubation, - for a surgical procedure which does not require the maintenance of myorelaxation. 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, - pregnant woman, - abdominal, thoracic or other surgical procedures requiring myorelaxation, - combination of general anesthesia and loco-regional anesthesia, - prior history of prolonged myorelaxation after administration of a drug metabolized by plasma cholinesterase - history of a homozygote deficit of plasma cholinesterase, - 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 pacemaker, - prevision of postoperative mechanical ventilation or sedation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are remifentanil doses, hemodynamics, patients' intraoperative mouvements, delay until extubation, awareness, performance of the closed-loop system.;Main Objective: Main objective is to compare propofol doses required to maintain the bispectral index between 40 and 60 during the maintenance of anesthesia between two groups : - group "curare" : patients will receive propofol and remifentanil (closed-loop administration using bispectral index as the controller) and mivacurium during the whole procedure - group "placebo" : patients will receive propofol and remifentanil (closed-loop administration using bispectral index as the controller) during the whole procedure and only one bolus dose of mivacurium (to facilite tracheal intubation). Saline will be infused during the maintenance period (placebo of mivacurium);Primary end point(s): Comparaison of propofol doses between the two groups of patients | — |
Countries
France
Outcome results
None listed