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…
ID
Bron
Verkorte titel
Aandoening
1. Propofol;
2. intracranial pressure;
3. sedation.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Pharmacokinetic and pharmacodynamic parameters (BIS, ICP), intra- and interindividual variability and identification of covariates.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Observational study.
Publiek
Department of Clinical Pharmacy
PO Box 2500
MYM Peeters
Nieuwegein 3430 EM
The Netherlands
0031306092612
mym.peeters@kf-antoniusmesosgroep.nl
Wetenschappelijk
Department of Clinical Pharmacy
PO Box 2500
MYM Peeters
Nieuwegein 3430 EM
The Netherlands
0031306092612
mym.peeters@kf-antoniusmesosgroep.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Known allergy for propofol or egg-lecithin;
2. pregnancy or lactation;
3. use of remifentanil.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL622 |
| NTR-old | NTR681 |
| Ander register | : |
| ISRCTN | Incomplete info for ISRCTN |