- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204268
The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery
September 16, 2010 updated by: Xijing Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hospital
-
Contact:
- Lize Xiong, MD,PhD
- Phone Number: 86-2984775337
- Email: lxiong@fmmu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Propofol group
Patients will receive the total intravenous anesthesia with propofol infusion during the surgery.
|
|
|
Active Comparator: Sevo-C group
Patients will receive the anesthesia with continuous inhalation of sevoflurane.
|
Patients will receive the anesthesia with continuous inhalation of sevoflurane.
|
|
Experimental: Sevo-I group
Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.
|
Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
S-100B,NSE
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Karnofsky Performance Scale,NIH stroke index, MMSE
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hailong Dong, MD, PhD, Xijing Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Anticipated)
August 1, 2011
Study Completion (Anticipated)
October 1, 2011
Study Registration Dates
First Submitted
September 15, 2010
First Submitted That Met QC Criteria
September 15, 2010
First Posted (Estimate)
September 17, 2010
Study Record Updates
Last Update Posted (Estimate)
September 20, 2010
Last Update Submitted That Met QC Criteria
September 16, 2010
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Intracranial Arterial Diseases
- Brain Ischemia
- Ischemia
- Aneurysm
- Intracranial Aneurysm
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Sevoflurane
Other Study ID Numbers
- APC-BRAIN-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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