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Pilot trial: Propofol in head-injured patients.


- candidate number2009
- NTR NumberNTR681
- ISRCTNIncomplete info for ISRCTN
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2006
- Secondary IDs 
- Public TitlePilot trial: Propofol in head-injured patients.
- Scientific TitlePropofol blood and cerebrospinal fluid pharmacokinetics and pharmacodynamics when used for sedation and control of increased intracranial pressure in head-injured intensive care patients.
- ACRONYMPropofol-CSF
- hypothesisBecause 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 criteria1. 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 criteria1. Known allergy for propofol or egg-lecithin;
2. pregnancy or lactation;
3. use of remifentanil.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 26-jan-2006
- planned closingdate1-aug-2006
- Target number of participants10
- InterventionsObservational study.
- Primary outcomePharmacokinetic and pharmacodynamic parameters (BIS, ICP), intra- and interindividual variability and identification of covariates.
- Secondary outcomeCorrelation GCS and Bispectral index for further investigation to study the clinical usefulness of the Bispectral index in severe brain-injured patients.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES MYM Peeters
- CONTACT for SCIENTIFIC QUERIES MYM Peeters
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryBackground:
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.
- Main changes (audit trail)
- RECORD9-mrt-2006 - 14-okt-2010


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