NCT01204268

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

September 20, 2010

Status Verified

August 1, 2009

Enrollment Period

2 years

First QC Date

September 15, 2010

Last Update Submit

September 16, 2010

Conditions

Brain Ischemia

Keywords

cerebral ischemiasevoflurane preconditioningintracranial aneurysm surgery

Outcome Measures

Primary Outcomes (1)

  • S-100B,NSE

    7 days

Secondary Outcomes (1)

  • Karnofsky Performance Scale,NIH stroke index, MMSE

    6 months

Study Arms (3)

Propofol group

NO INTERVENTION

Patients will receive the total intravenous anesthesia with propofol infusion during the surgery.

Sevo-C group

ACTIVE COMPARATOR

Patients will receive the anesthesia with continuous inhalation of sevoflurane.

Procedure: Sevo continuous inhalation

Sevo-I group

EXPERIMENTAL

Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.

Procedure: Sev-I group

Interventions

Sev-I groupPROCEDURE

Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.

Also known as: Sevoflurane preconditioning
Sevo-I group
Sevo continuous inhalationPROCEDURE

Patients will receive the anesthesia with continuous inhalation of sevoflurane.

Sevo-C group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient under intracranial aneurysm surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hailong Dong, MD, PhD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 17, 2010

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

October 1, 2011

Last Updated

September 20, 2010

Record last verified: 2009-08

Locations

CN(1)