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

Phase 3TerminatedNCT00336882

Rennes University Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

PropofolDRUG

Propofol at a dose of 1 mg/kg/hour with a dose increase of 1 mg/kg until therapeutic effect (with a maximum dose of 5 mg/kg/hour)

MidazolamDRUG

Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Réanimation Chirurgicale - Hôpital de Pontchaillou

Rennes, France

Outcomes

Primary Outcomes

Lactate/pyruvate ratio concentration measured in the brain by microdialysis during the first 72 h of treatment

Time frame: 72 hours

Secondary Outcomes

Glutamate, glucose and glycerol concentration measured in the brain by microdialysis during the first 72 h of treatment.

Time frame: 72 hours

Glasgow outcome scale and Mc Nair score at 12 months.

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.