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

NCT00336882 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-03-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Propofol

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)

DRUG

Midazolam

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Yannick Mallédant, MD, PhD · Rennes University Hospital

  • Bruno Laviolle, MD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-10-31
Completion
2010-02-28

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00336882 on ClinicalTrials.gov