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Clinical Trials/NCT00866489
NCT00866489
Completed
Phase 1

Clinical Trial Cencer, Xijing Hospital, Fourth Military Medical University

Xijing Hospital0 sites70 target enrollmentSeptember 2008
Conditionss100b

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
s100b
Sponsor
Xijing Hospital
Enrollment
70
Primary Endpoint
S-100b and NSE level
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The current study is designed to clarify the neuroprotective effect of remote ischemic precondtioning on the patients underwent neurosurgery.

Detailed Description

BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and mortality after neurosurgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective neurosurgery, a randomized trial will be performed in current study. DESIGNING Thirty patients undergoing craniotomy for supratentorial meningioma will be randomize assigned to neurosurgery with RIPC or conventional neurosurgery (control). Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was assessed by S-100b, NSE, and neurological function scores in different time points. EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury. CONCLUSIONS: In patients undergoing elective craniotomy for supratentorial meningioma, RIPC reduces the incidence of postoperative cerebral injury.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
September 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xijing Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients referred for primary elective neurosurgery were invited to participate in the study at the time of scheduling for operation

Exclusion Criteria

  • Potential participants were excluded if they were \>70 years of age
  • Required concomitant procedures other than neurosurgery
  • Had experienced an acute coronary syndrome or myocardial infraction within 3 months
  • Were unable to give informed consent
  • Were taking sulfonylurea oral hypoglycemic agents or nicorandil drug therapy because these agents have been shown to effect preconditioning.

Outcomes

Primary Outcomes

S-100b and NSE level

Time Frame: 7 days

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