Brain InjuryPhase 2SEPIANCT01374633
Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
A Phase 2 study testing 1: Sevoflurane in people with Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury
- What is being tested?
- 1: Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe traumatic brain injury (glasgow < 8)
- age > 18
- no surgery scheduled
- sedation with midazolam and sufentanil
- ICP sensor
Who cannot join
- external ventricular derivation
- pregnancy
- antecedent of malign hyperthermia
- haemodynamic instability
Trial locations and contacts
1 site in 1 country.
France1 site
Reanimation Chirurgicale - Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, 94275
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Injury
- Being tested
- 1: Sevoflurane
- Keywords
- Sevoflurane, Brain injury, Intra cranial pressure, Sedation, Brain injury with initial Glasgow score less than 9
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1: SevofluraneDrug
Also called SEVORANE (Abbott), SEVOFLURANE (Baxter)
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."
| Study group | Role | What they receive |
|---|---|---|
| 1:patient with severe traumatic brain | Experimental | Not described Receives: Drug: 1: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: ICP will be continuously recorded during the 12 hours of sedation with sevoflurane
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: during the 12 hours of sedation with sevoflurane
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jacques DURANTEAU, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374633
- Sponsor's protocol ID
- P100206
- Other IDs
- 2011-000253-23
- Acronym
- SEPIA
- Status last verified
- Mar 2015
- First submitted
- 8 Jun 2011
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT01374633
- Acronym / sponsor ID
- SEPIA / P100206
- Conditions
- Brain Injury
- Keywords
- Sevoflurane, Brain injury, Intra cranial pressure, Sedation, Brain injury with initial Glasgow score less than 9
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1:patient with severe traumatic brain | Experimental | Drug: 1: Sevoflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- severe traumatic brain injury (glasgow < 8)
- age > 18
- no surgery scheduled
- sedation with midazolam and sufentanil
- ICP sensor
Key exclusion criteria (4 listed)
- external ventricular derivation
- pregnancy
- antecedent of malign hyperthermia
- haemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1: SevofluraneAlso: SEVORANE (Abbott), SEVOFLURANE (Baxter)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." | Drug | 1:patient with severe traumatic brain |
Primary outcome
ICP evolution
Time frame: ICP will be continuously recorded during the 12 hours of sedation with sevoflurane
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".
3 secondary outcomes
Sedation level
Time frame: during the 12 hours of sedation with sevoflurane
Haemodynamic tolerance
Time frame: during the 12 hours of sedation with sevoflurane
Malignant hyperthermia screening
Time frame: during the 12 hours of sedation with sevoflurane
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques DURANTEAU, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1: Sevoflurane in people with Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICP evolution (time frame: ICP will be continuously recorded during the 12 hours of sedation with sevoflurane). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.