Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients (SEPIA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Brain Injury
• Intervention / Treatment: Drug: 1: Sevoflurane

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Kremlin Bicêtre, France, 94275
    • Reanimation Chirurgicale - Hôpital Kremlin Bicêtre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1:patient with severe traumatic brain	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."; Other Names: SEVORANE (Abbott); SEVOFLURANE (Baxter)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 15, 2011
• First Posted (ESTIMATE): June 16, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Sedation; Sevoflurane; Brain injury; Intra cranial pressure; Brain injury with initial Glasgow score less than 9
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: P100206; 2011-000253-23 (OTHER: Eudra CT)