Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

NCT01374633 | Terminated Phase 2 DMC

• 2 other identifiers: P1002062011-000253-23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury

Keywords

Sevoflurane; Brain injury; Intra cranial pressure; Sedation; Brain injury with initial Glasgow score less than 9

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sedation level

  during the 12 hours of sedation with sevoflurane

• Haemodynamic tolerance

  during the 12 hours of sedation with sevoflurane

• Malignant hyperthermia screening

  during the 12 hours of sedation with sevoflurane

Study Arms (1)

1:patient with severe traumatic brain

EXPERIMENTAL

Drug: 1: Sevoflurane

Interventions

1: Sevoflurane DRUG

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."

Also known as: SEVORANE (Abbott), SEVOFLURANE (Baxter)

1:patient with severe traumatic brain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe traumatic brain injury (glasgow \< 8)
• age \> 18
• no surgery scheduled
• sedation with midazolam and sufentanil
• ICP sensor

You may not qualify if:

• external ventricular derivation
• pregnancy
• antecedent of malign hyperthermia
• haemodynamic instability

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Reanimation Chirurgicale - Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Jacques DURANTEAU, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 16, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

FR (1)