Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01204268
First received: September 15, 2010
Last updated: September 16, 2010
Last verified: August 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Sevoflurane
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014