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The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery

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ClinicalTrials.gov Identifier: NCT01204268
Recruitment Status : Unknown
Verified August 2009 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : September 17, 2010
Last Update Posted : September 20, 2010
Sponsor:
Information provided by:
Xijing Hospital

Brief Summary:
The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery.

Condition or disease Intervention/treatment
Brain Ischemia Procedure: Sev-I group Procedure: Sevo continuous inhalation

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Neuroprotection of Sevoflurane Preconditioning on Perioperative Ischemia-reperfusion Injury During Intracranial Aneurysm Surgery
Study Start Date : August 2009
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane
U.S. FDA Resources

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.
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



Primary Outcome Measures :
  1. S-100B,NSE [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Karnofsky Performance Scale,NIH stroke index, MMSE [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hailong Dong, Xijing Hospital, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01204268     History of Changes
Other Study ID Numbers: APC-BRAIN-2009
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: September 20, 2010
Last Verified: August 2009

Keywords provided by Xijing Hospital:
cerebral ischemia
sevoflurane preconditioning
intracranial aneurysm surgery

Additional relevant MeSH terms:
Ischemia
Aneurysm
Intracranial Aneurysm
Brain Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs