Pilot trial: Propofol in head-injured patients.

Propofol blood and cerebrospinal fluid pharmacokinetics and pharmacodynamics when used for sedation and control of increased intracranial pressure in head-injured intensive care patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22558

Enrollment

Registered

2006-03-09

Start date

2006-01-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Propofol

Interventions

Observational study.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Severe traumatic brain injury (GCS =18, men en women; 5. possibility to locate BIS sensors.

Exclusion criteria

Exclusion criteria: 1. Known allergy for propofol or egg-lecithin; 2. pregnancy or lactation; 3. use of remifentanil.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic and pharmacodynamic parameters (BIS, ICP), intra- and interindividual variability and identification of covariates.	—

Secondary

Measure	Time frame
Correlation GCS and Bispectral index for further investigation to study the clinical usefulness of the Bispectral index in severe brain-injured patients.	—

Contacts

Public ContactMYM Peeters

St Antonius Hospital Department of Clinical Pharmacy PO Box 2500

mym.peeters@kf-antoniusmesosgroep.nl0031306092612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)