Brain IschemiaNCT01204268
The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery
A study testing Sev-I group and Sevo continuous inhalation in people with Brain Ischemia, run by Xijing Hospital at 1 site in China.
Trial summary
The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Ischemia
- What is being tested?
- Sev-I group and Sevo continuous inhalation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Oct 2011
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient under intracranial aneurysm surgery.
Who cannot join
- Patients who refused to participate or who had a history of chemotherapy/convulsions two weeks prior to admission, stroke/cardiopulmonary resuscitation/head trauma three months prior to admission, Alzheimer's disease, amyotrophic lateral sclerosis, and prior melanoma were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Lize Xiong, MD,PhD, 86-2984775337, lxiong@fmmu.edu.cn
About this study
Official title: The Neuroprotection of Sevoflurane Preconditioning on Perioperative Ischemia-reperfusion Injury During Intracranial Aneurysm Surgery
The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery.
Read the detailed description
The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery. The patients with cerebral aneurysm will be recruited in current study. The sevoflurane preconditioning will be performed before the surgical procedure. The neurological injury biomarkers, such as S-100b and NSE will be detected. The neurological function and recovery will be assessed after the surgery.
- Conditions
- Brain Ischemia
- Being tested
- Sev-I group, Sevo continuous inhalation
- Keywords
- cerebral ischemia, sevoflurane preconditioning, intracranial aneurysm surgery
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sev-I groupProcedure or surgery
Also called Sevoflurane preconditioning
Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.
Sevo continuous inhalationProcedure or surgery
Patients will receive the anesthesia with continuous inhalation of sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | No intervention | Patients will receive the total intravenous anesthesia with propofol infusion during the surgery. |
| Sevo-C group | Active comparator | Patients will receive the anesthesia with continuous inhalation of sevoflurane. Receives: Procedure: Sevo continuous inhalation |
| Sevo-I group | Experimental | Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury. Receives: Procedure: Sev-I group |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-100B,NSE
Measured: 7 days
Secondary outcomes (1)
Karnofsky Performance Scale,NIH stroke index, MMSE
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hailong Dong, MD, PhD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204268
- Sponsor's protocol ID
- APC-BRAIN-2009
- Status last verified
- Aug 2009
- First submitted
- 15 Sep 2010
- Last updated
- 20 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroprotection of Sevoflurane Preconditioning on Perioperative Ischemia-reperfusion Injury During Intracranial Aneurysm Surgery
- ClinicalTrials.gov ID
- NCT01204268
- Acronym / sponsor ID
- APC-BRAIN-2009
- Conditions
- Brain Ischemia
- Keywords
- cerebral ischemia, sevoflurane preconditioning, intracranial aneurysm surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 17 Sep 2010 (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.
The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery.
Detailed description
The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery. The patients with cerebral aneurysm will be recruited in current study. The sevoflurane preconditioning will be performed before the surgical procedure. The neurological injury biomarkers, such as S-100b and NSE will be detected. The neurological function and recovery will be assessed after the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol group | No intervention | –Patients will receive the total intravenous anesthesia with propofol infusion during the surgery. |
| Sevo-C group | Active comparator | Procedure: Sevo continuous inhalationPatients will receive the anesthesia with continuous inhalation of sevoflurane. |
| Sevo-I group | Experimental | Procedure: Sev-I groupSevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient under intracranial aneurysm surgery.
Key exclusion criteria (1 listed)
- Patients who refused to participate or who had a history of chemotherapy/convulsions two weeks prior to admission, stroke/cardiopulmonary resuscitation/head trauma three months prior to admission, Alzheimer's disease, amyotrophic lateral sclerosis, and prior melanoma were excluded.
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 |
|---|---|---|
| Sev-I groupAlso: Sevoflurane preconditioningSevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury. | Procedure or surgery | Sevo-I group |
| Sevo continuous inhalationPatients will receive the anesthesia with continuous inhalation of sevoflurane. | Procedure or surgery | Sevo-C group |
Primary outcome
S-100B,NSE
Time frame: 7 days
1 secondary outcome
Karnofsky Performance Scale,NIH stroke index, MMSE
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2010.
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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.
Hailong Dong, MD, PhD principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sev-I group and Sevo continuous inhalation in people with Brain Ischemia, run by Xijing Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Sep 2010. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S-100B,NSE (time frame: 7 days). 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 20 Sep 2010.