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). A covariate analysis will be performed…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective is to develop a pharmacokinetic model of Propofol when used
for induction and maintenance of anaesthesia in the morbidly obese patient.
Primary endpoints: pharmacokinetic parameters; clearance, intercompartmental
clearance, volume of central compartment and volume of peripheral compartment.
Secondary outcome
The secondary objective is to develop a pharmacodynamic model of Propofol when
used for induction and maintenance of anaesthesia in morbidly obese patients.
Secondary endpoints: pharmacodynamic parameters; time to induction of
anaesthesia (stop counting, eyelash reflex, quality of anaesthesia,
corresponding dose required for induction of anaesthesia for both induction
doses), EC50 using BIS, required doses of Propofol during maintenance of
anaesthesia, wake-up time.
Background summary
The extreme increase of obesity in the last years had led to this study. There
is no consensus about how to anaesthetise morbidly obese patients. The amounts
of narcotics given vary widely and rather depend on the anaesthetist than on
the pharmacokinetics and dynamics in the morbidly obese patient. Reason for
this is that it is not clear in what extend the pharmacokinetics and dynamics
are affected in the morbidly obese patient.
Study objective
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). A covariate analysis will
be performed in order to account for variability in pharmacokinetic and/or
pharmacodynamic parameters. This model will take into account patient and
procedure bound covariates. The results will be used to develop individualised
dosing schemes of Propofol when used for induction and maintenance of
anaesthesia in morbidly obese patients.
Study design
A randomised, therapeutic and non-invasive study.
Intervention
Patients will be randomised into two groups, one group will be given 200
milligrams of Propofol and the other group will be given 350 milligrams of
Propofol. During the induction of anaesthesia with Propofol over 60 seconds,
the patient is asked to count in order to measure time to induction of
anaesthesia. During and following anaesthesia blood samples will be taken from
an indwelling arterial line with a maximum amount of 50 ml.
Study burden and risks
A maximum amount of 50 milliliters of blood will be sampled from an indwelling
arterial line. The patient will be asked to count slowly during induction of
anaesthesia. Both induction doses of 200 and 350 milligrams are currently used
standard induction doses for morbidly obese patients.
govert flinckstraat 240
1073 CD Amsterdam
Nederland
govert flinckstraat 240
1073 CD Amsterdam
Nederland
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-005670-45-NL |
| CCMO | NL13980.100.06 |