The study is performed in order to develop population pharmacokinetic and/or pharmacodynamic models of the standard used drug therapies during surgery in morbidly obese patients (BMI > 40 kg/m2): cefazolin, morphine, nadroparin and atracurium.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints to evaluate in morbidly obese patients are;
- pharmacokinetic parameters of cefazolin in blood;
- pharmacokinetic parameters of morphine and metabolites in blood;
- time course of anti-factor Xa levels in blood following nadroparin;
- time course of the pharmacodynamic effect of atracurium.
Secondary outcome
Secondary endpoints to evaluate in morbidly obese patients are:
- to compare primary endpoints (obtained in morbidly obese patients) with data
of non-obese patients
- the occurrence of postoperative wound infections;
- postoperative pain scores, sedation scores and nausea scores;
- the occurrence of bleedings or thrombotic events ;
- required amounts of morphine (PCA);
- to compare the time course of the pharmacodynamic effect of two different
doses of atracurium.
Background summary
Obesity is an increasing health risk worldwide, with the USA recording a
prevalence in adults of around 20%. The mean body weight of obese patients is
also increasing. One of the strategies to treat extreme obesity (Body Mass
Index (BMI) > 40 kg/m2) is weight reducing surgery like laparoscopic gastric
banding or gastric bypass. During this type of surgery or any other surgery,
morbidly obese patients can be more difficult to intubate and are at higher
risk of wound infections and thrombotic events. Routinely, amongst others,
cefazolin, morphine, nadroparin and atracurium are administered in standard
dosages. However, it is not known to what extend the pharmacokinetics and
-dynamics of these drugs are affected in morbidly obese patients. Therefore,
development of evidence-based dosing schedules for these drugs in morbidly
obese patients is becoming more important.
Study objective
The study is performed in order to develop population pharmacokinetic and/or
pharmacodynamic models of the standard used drug therapies during surgery in
morbidly obese patients (BMI > 40 kg/m2): cefazolin, morphine, nadroparin and
atracurium. Whenever possible, the results will be compared to non-obese
patients. 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 these drugs in morbidly
obese patients for daily practice.
Study design
A randomised, prospective, observational, therapeutic and invasive study.
Study burden and risks
A maximum amount of 70 millilitres of blood will be sampled from an indwelling
arterial line during and after surgery. The arterial line will be kept in place
5 hours longer than usual. Postoperatively the patient will be asked to rate
his pain and nausea every hour after surgery. To evaluate sedation levels the
Ramsay scale will be scored every 3 hours after surgery. After 1 week the
patient will be checked for thrombosis using ultrasonography.
koekoekslaan 1
3430 EM
Nederland
koekoekslaan 1
3430 EM
Nederland
Listed location countries
Age
Inclusion criteria
Patients with a Body Mass Index > 40 kg/m2 undergoing laparoscopic banding or gastric bypass surgery, 18-60 years old, American Society of Anaesthesiologists (ASA) physical status II to III.
Exclusion criteria
Pregnancy, breastfeeding, known allergy for cefazolin, morphine, nadroparin, atracurium, or benzene sulphonic acid. History of coagulation disorder or history of heparin/LMWH induced thrombocytopenia.
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 |
|---|---|
| CCMO | NL27407.100.09 |
| Other | volgt |