The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery

Brain Ischemia Clinical Trial

Official title:

The Neuroprotection of Sevoflurane Preconditioning on Perioperative Ischemia-reperfusion Injury During Intracranial Aneurysm Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01204268
• Other study ID #: APC-BRAIN-2009
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2010
• Last updated: September 16, 2010
• Start date: August 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2009
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science FoundationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aneurysm
• Brain Ischemia
• Intracranial Aneurysm
• Ischemia

Intervention

Procedure:
• Sev-I group
Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.
• Sevo continuous inhalation
Patients will receive the anesthesia with continuous inhalation of sevoflurane.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S-100B,NSE		7 days	Yes
Secondary	Karnofsky Performance Scale,NIH stroke index, MMSE		6 months	Yes