Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

Brain Injury Clinical Trial

— SEPIA  

Official title:

Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01374633
• Other study ID #: P100206
• Secondary ID: 2011-000253-23
• Status: Terminated
• Phase: Phase 2
• First received: June 8, 2011
• Last updated: March 26, 2015
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• severe traumatic brain injury (glasgow < 8)

• age > 18

• no surgery scheduled

• sedation with midazolam and sufentanil

• ICP sensor

Exclusion Criteria:

• external ventricular derivation

• pregnancy

• antecedent of malign hyperthermia

• haemodynamic instability

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury

Intervention

Drug:
• 1: Sevoflurane
Mean sevoflurane infusion rate will be around 6 ml/h or 72 ml for 12 hours. Maximal infusion rate will be around 12 ml/h, or 144 ml for 12 hours. Packaging: bottle containing 250 ml of liquid sevoflurane for evaporation. Administration mode: anaesthetic conserving device for volatile anaesthetics."

Locations

Country	Name	City	State
France	Reanimation Chirurgicale - Hôpital Kremlin Bicêtre	Kremlin Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICP evolution	patients where ICP increase more than 30 mmHg during more than 15 minutes will be characterized as "failure". Patients whose ICP do not increase during the 12 hours of sedation with sevoflurane will be characterized as "success".	ICP will be continuously recorded during the 12 hours of sedation with sevoflurane	Yes
Secondary	Sedation level	sedation level will be evaluated with the measure of the Bispectral Index and the SAS sedation score. Proportion of time with BIS of 45-65% and SAS <2, which are the objective of sedation level, will be recorded.	during the 12 hours of sedation with sevoflurane	Yes
Secondary	Haemodynamic tolerance	invasive mean arterial pressure (MAP) will be continuously recorded. Hypotension is defined by a MAP less than 60 mmHg.	during the 12 hours of sedation with sevoflurane	Yes
Secondary	Malignant hyperthermia screening	increase of eardrum temperature more than 39°C is considered as potential malignant hyperthermia	during the 12 hours of sedation with sevoflurane	Yes