The study is performed in order to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in the morbidly obese patient (BMI > 40).
Conditions
Interventions
Trade Name: Propofol
Pharmaceutical Form: Intravenous infusion
Sponsors
St. Antonius hospital Nieuwegein
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Morbidly obese patients with a Body Mass Index > 40 undergoing laparoscopic banding or gastric bypass surgery, 18-60 year old. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Epilepsy, pregnancy, breastfeeding and known allergy for Propofol, egg lecithin or soy bean oil.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to develop a pharmacokinetic model of Propofol when used for induction and maintenance of anaesthesia in the morbidly obese patient.;Secondary Objective: The secondary objective is to develop a pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in morbidly obese patients. ;Primary end point(s): Primary endpoints: pharmacokinetic parameters; clearance, intercompartmental clearance, volume of central compartment and volume of peripheral compartment. | — |
Countries
Netherlands
Outcome results
None listed