No registrations found.
ID
Source
Brief title
Health condition
1. Propofol;
2. intracranial pressure;
3. sedation.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetic and pharmacodynamic parameters (BIS, ICP), intra- and interindividual variability and identification of covariates.
Secondary outcome
Correlation GCS and Bispectral index for further investigation to study the clinical usefulness of the Bispectral index in severe brain-injured patients.
Background summary
Background:
Little is known about the dose regimen of propofol in patients with increased intracranial pressure. Especially in neurological patients and long-term high-doses, knowledge of PK and PD of propofol is important, since propofol is associated with the propofol-infusion syndrome.
Method:
Propofol cerebrospinal fluid and whole blood samples will be determined simultaneously. The Bispectral analysis is recorded in addition to the GCS. Population PK and PD modelling will be performed with NONMEM.
Study objective
Because little is known on the effective and safe dosage of propofol when used for control of intracranial pressure in head-injured patients, propofol blood and cerebrospinal fluid concentrations and pharmacodynamics are characterized in order to optimize dose regimens.
The bispectral index (BIS) may be of additional value to assess the depth of sedation and the neurological outcome in head-injured intensive care patients.
Study design
N/A
Intervention
Observational study.
Department of Clinical Pharmacy
PO Box 2500
MYM Peeters
Nieuwegein 3430 EM
The Netherlands
0031306092612
mym.peeters@kf-antoniusmesosgroep.nl
Department of Clinical Pharmacy
PO Box 2500
MYM Peeters
Nieuwegein 3430 EM
The Netherlands
0031306092612
mym.peeters@kf-antoniusmesosgroep.nl
Inclusion criteria
1. Severe traumatic brain injury (GCS <=8);
2. indication propofol for sedation and control of increased intracranial pressure;
3. presence of intraventricular drain;
4. age >=18, men en women;
5. possibility to locate BIS sensors.
Exclusion criteria
1. Known allergy for propofol or egg-lecithin;
2. pregnancy or lactation;
3. use of remifentanil.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL622 |
| NTR-old | NTR681 |
| Other | : |
| ISRCTN | Incomplete info for ISRCTN |