Pilot trial: Propofol in head-injured patients.
Completed
- Conditions
- 1. Propofol<br />2. intracranial pressure<br />3. sedation.
- Registration Number
- NL-OMON22558
- Lead Sponsor
- niversity Medical Center Groningen, Department of Neurology, the Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Severe traumatic brain injury (GCS <=8);
2. indication propofol for sedation and control of increased intracranial pressure;
Exclusion Criteria
1. Known allergy for propofol or egg-lecithin;
2. pregnancy or lactation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic and pharmacodynamic parameters (BIS, ICP), intra- and interindividual variability and identification of covariates.
- Secondary Outcome Measures
Name Time Method Correlation GCS and Bispectral index for further investigation to study the clinical usefulness of the Bispectral index in severe brain-injured patients.