The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Xijing Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Xijing Hospital
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01204268
First received: September 15, 2010
Last updated: September 16, 2010
Last verified: August 2009
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Purpose
The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery.
| Condition | Intervention |
|---|---|
|
Brain Ischemia |
Procedure: Sev-I group Procedure: Sevo continuous inhalation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Neuroprotection of Sevoflurane Preconditioning on Perioperative Ischemia-reperfusion Injury During Intracranial Aneurysm Surgery |
Resource links provided by NLM:
Further study details as provided by Xijing Hospital:
Primary Outcome Measures:
- S-100B,NSE [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Karnofsky Performance Scale,NIH stroke index, MMSE [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Procedure: Sevo continuous inhalation
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.
|
Procedure: Sev-I group
Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.
Other Name: Sevoflurane preconditioning
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204268
Locations
| China, Shaanxi | |
| Xijing Hospital | Recruiting |
| Xi'an, Shaanxi, China, 710032 | |
| Contact: Lize Xiong, MD,PhD 86-2984775337 lxiong@fmmu.edu.cn | |
Sponsors and Collaborators
Xijing Hospital
Investigators
| Principal Investigator: | Hailong Dong, MD, PhD | Xijing Hospital |
More Information
No publications provided
| Responsible Party: | Hailong Dong, Xijing Hospital, Fourth Military Medical University |
| ClinicalTrials.gov Identifier: | NCT01204268 History of Changes |
| Other Study ID Numbers: | APC-BRAIN-2009 |
| Study First Received: | September 15, 2010 |
| Last Updated: | September 16, 2010 |
| Health Authority: | China: National Natural Science Foundation China: Food and Drug Administration |
Keywords provided by Xijing Hospital:
|
cerebral ischemia sevoflurane preconditioning intracranial aneurysm surgery |
Additional relevant MeSH terms:
|
Intracranial Aneurysm Aneurysm Brain Ischemia Ischemia Reperfusion Injury Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pathologic Processes |
Postoperative Complications Sevoflurane Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013