Population pharmacokinetics/pharmacodynamics of Propofol in morbidly obese patients - POP

• Conditions: 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).

• Registration Number: EUCTR2006-005670-45-NL
• Lead Sponsor: St. Antonius hospital Nieuwegein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Epilepsy, pregnancy, breastfeeding and known allergy for Propofol, egg lecithin or soy bean oil.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.