Population pharmacokinetics/pharmacodynamics of Propofol in morbidly obese patients
Completed
- Conditions
- morbide obesitasmorbid obesityobese
- Registration Number
- NL-OMON31661
- Lead Sponsor
- anesthesiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion Criteria
Morbidly obese patients with a Body Mass Index > 40 undergoing laparoscopic banding or gastric bypass surgery, 18-60 year old.
Exclusion Criteria
Epilepsy, pregnancy, breastfeeding and known allergy for Propofol, egg lecithin or soy bean oil.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main objective is to develop a pharmacokinetic model of Propofol when used<br /><br>for induction and maintenance of anaesthesia in the morbidly obese patient.<br /><br>Primary endpoints: pharmacokinetic parameters; clearance, intercompartmental<br /><br>clearance, volume of central compartment and volume of peripheral compartment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective is to develop a pharmacodynamic model of Propofol when<br /><br>used for induction and maintenance of anaesthesia in morbidly obese patients.<br /><br>Secondary endpoints: pharmacodynamic parameters; time to induction of<br /><br>anaesthesia (stop counting, eyelash reflex, quality of anaesthesia,<br /><br>corresponding dose required for induction of anaesthesia for both induction<br /><br>doses), EC50 using BIS, required doses of Propofol during maintenance of<br /><br>anaesthesia, wake-up time. </p><br>