general anaesthesia MedDRA version: 9.1 Level: LLT Classification code 10002323 Term: Anesthesia general
Conditions
Interventions
Trade Name: Propofol Frésénius
Product Name: Propofol
Pharmaceutical Form: Intravenous infusion
Trade Name: Ultiva
Product Name: Ultiva
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Hopital Foch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients scheduled for a bariatric coelioscopic surgical procedure (obese patients) ou for a SUS-OBOLICAL coelioscopic surgical procedure (lean patients) 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, - presence of a central neurological disorder or a lesion cerebral, of a severe respiratory or hepatic insufficiency, - allergy to propofol, or to soja or to peanuts, or to sufentanil, or to remifentanil, or to morphine, or to a muscle myorelaxant, or to an excipient, - hypersensibility to sufentanil, or to remifentanil or to another derivate of fentanyl, - allergy to latex, - presence of a gastroesophageal reflux or of a hiatal hernia, - patients receiving a psychotropic treatment or a agonist-antagonist opiate, - presence of predictive signs of difficult mask ventilation of difficult intubation (else than obesity).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to sompare the porpofol and remifentanil doses required to maintain the bispectral index in the range 40-0 in two groups of patients: - obese patients - lean patients.;Secondary Objective: The secondary objectives are intraoperative haemodynamic profile, time to extubation and the performances of the automated system of propfol and remifentanil delivery.;Primary end point(s): Dose of propofol administered intraoperatively | — |
Countries
France
Outcome results
None listed