|- candidate number||2009|
|- NTR Number||NTR681|
|- ISRCTN||Incomplete info for ISRCTN|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-mrt-2006|
|- Secondary IDs|| |
|- Public Title||Pilot trial: Propofol in head-injured patients.|
|- Scientific Title||Propofol blood and cerebrospinal fluid pharmacokinetics and pharmacodynamics when used for sedation and control of increased intracranial pressure in head-injured intensive care patients.|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||26-jan-2006|
|- planned closingdate||1-aug-2006|
|- Target number of participants||10|
|- Interventions||Observational study.|
|- 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.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| MYM Peeters|
|- CONTACT for SCIENTIFIC QUERIES|| MYM Peeters|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief 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.
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.
|- Main changes (audit trail)|
|- RECORD||9-mrt-2006 - 14-okt-2010|