Viewing Study NCT00336882



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00336882
Status: TERMINATED
Last Update Posted: 2012-03-02
First Post: 2006-06-13

Brief Title: Anaesthesia With Propofol Versus Midazolam Effect on Oxidative Stress in the Brain of Head Trauma Patients
Sponsor: Rennes University Hospital
Organization: Rennes University Hospital

Study Overview

Official Title: Anaesthesia With Propofol Versus Midazolam Effect on Oxidative Stress in the Brain of Head Trauma Patients
Status: TERMINATED
Status Verified Date: 2012-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PROMIS
Brief 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
Detailed Description: 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 Measurements will be performed by use of intracerebral microdialysis

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CIC0203053 Other Identifier Rennes University Hospital None
PHRC05-02 OTHER None None