Back to resultsThe Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery
Primary Purpose
Brain Ischemia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sev-I group
Sevo continuous inhalation
Sponsored by
About this trial
This is an interventional prevention trial for Brain Ischemia focused on measuring cerebral ischemia, sevoflurane preconditioning, intracranial aneurysm surgery
Eligibility Criteria
Inclusion Criteria:
- Patient under intracranial aneurysm surgery.
Exclusion Criteria:
- 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.
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Propofol group
Sevo-C group
Sevo-I group
Arm Description
Patients will receive the total intravenous anesthesia with propofol infusion during the surgery.
Patients will receive the anesthesia with continuous inhalation of sevoflurane.
Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.
Outcomes
Primary Outcome Measures
S-100B,NSE
Secondary Outcome Measures
Karnofsky Performance Scale,NIH stroke index, MMSE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01204268
Brief Title
The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery
Official Title
The Neuroprotection of Sevoflurane Preconditioning on Perioperative Ischemia-reperfusion Injury During Intracranial Aneurysm Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia
Keywords
cerebral ischemia, sevoflurane preconditioning, intracranial aneurysm surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol group
Arm Type
No Intervention
Arm Description
Patients will receive the total intravenous anesthesia with propofol infusion during the surgery.
Arm Title
Sevo-C group
Arm Type
Active Comparator
Arm Description
Patients will receive the anesthesia with continuous inhalation of sevoflurane.
Arm Title
Sevo-I group
Arm Type
Experimental
Arm Description
Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.
Intervention Type
Procedure
Intervention Name(s)
Sev-I group
Other Intervention Name(s)
Sevoflurane preconditioning
Intervention Description
Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.
Intervention Type
Procedure
Intervention Name(s)
Sevo continuous inhalation
Intervention Description
Patients will receive the anesthesia with continuous inhalation of sevoflurane.
Primary Outcome Measure Information:
Title
S-100B,NSE
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Karnofsky Performance Scale,NIH stroke index, MMSE
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient under intracranial aneurysm surgery.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hailong Dong, MD, PhD
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lize Xiong, MD,PhD
Phone
86-2984775337
Email
lxiong@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery
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