Overview

Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients

Status:
Terminated

Trial end date:
2010-02-01

Target enrollment:
0

Participant gender:
All

Summary

Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rennes University Hospital

Collaborator:

Ministry of Health, France

Treatments:

Midazolam
Propofol

Criteria

Inclusion Criteria:

Age≥18 years, Severe traumatic brain injury with a Glasgow coma scale ≤8 related to the
trauma, Stage II, III or IV of the US Trauma Data Bank on the CT scan, Need for
intracranial pressure monitoring, Written informed consent from the patient's next-of-kin.
If no relative is present as the time of inclusion, the patients will be included according
to the emergency procedure.

Non-inclusion Criteria:

Traumatic brain injury requiring urgent neurosurgical intervention due to blood collection,
Contraindication to propofol or midazolam, History of head trauma > 12 hours before intra
cranial pressure monitoring, Patient receiving propofol by continuous infusion since head
trauma.