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
Product Name: Dexmedetomidine
Sponsors
Hopital Foch
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male patients scheduled for general anesthesia performed under controlled ventilation. 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, - 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, - hypovolemia - patient treated by a cardio-vascular drug - presence of a pacemaker, - prevision of significant operative bleeding, - patient with severe hepatic insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 "dexmedetomidine" : patients will receive propofol and remifentanil (closed-loop administration using bispectral index as the controller) and dexmedetomidine during the whole procedure - group "placebo" : patients will receive propofol and remifentanil (closed-loop administration using bispectral index as the controller) and placebo during the whole procedure ;Secondary Objective: Secondary objectives are remifentanil doses, intraoperative hemodynamics, pain scores in the recovery room, awareness;Primary end point(s): Comparaison of propofol doses between the two groups of patients | — |
Countries
France
Outcome results
None listed