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

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 2

Conditions: Brain Injury

Treatments: Drug: 1: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT01374633

2011-000253-23 (Other Identifier)

P100206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

1:patient with severe traumatic brain

Experimental group

Treatment:

Drug: 1: Sevoflurane