Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-27 @ 11:20 PM
Study NCT ID:
NCT01374633
Status:
TERMINATED
Last Update Posted:
2015-03-27
First Post:
2011-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEPIA
Brief Summary:
Main purpose of the study is to evaluate the effect of sevoflurane on intra cranial pressure (ICP) after traumatic brain injury. Patients admitted for traumatic brain injury equipped with ICP measurement will be sedated with sevoflurane via the Anaconda device during 12 hours. Sedation will be controlled with BIS.
Detailed Description:
Sedation is most of the time required for ICP management after traumatic brain injury. Sevoflurane, an inhaled anaesthetic drug is commonly used in operatory room. Thanks to a new device, the Anaconda, it now can be applied to intensive care patients. His advantages a rapid elimination after administration stops, which can allow an early neurologic evaluation, very important for traumatic brain injury patients.We will study the effect of sevoflurane administration on ICP of TBI patients. Patients admitted for severe TBI (Glasgow come scale \< 8), equipped with ICP sensor, elder than 18 years old will be include. A sedation with sevoflurane will be administrated during 12 hours instead of classical intra venous sedation with midazolam, depending on BIS score. ICP evolution will be characterised in success if \< 30 mmHg or failure if ≥ 30 mmHg.6 patients will be included for the first phase. The study will be stopped if the failures are ≥ 2. Otherwise, 27 patients will be included. Study will be stopped if failures number ≥ 5 before the end if the inclusion period.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-000253-23 | OTHER | Eudra CT | View |