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The Neuroprotective Effects of RPC on the Neurosurgery

NCT ID: NCT00866489

Last Updated: 2010-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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s100b

Keywords

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Experimental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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sham RIPC

Patients had a deflated cuff placed on the right upper arm for 30 min.

Group Type NO_INTERVENTION

No interventions assigned to this group

RIPC

RIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated

Group Type EXPERIMENTAL

remote preconditioning

Intervention Type PROCEDURE

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.

Interventions

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remote preconditioning

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.

Intervention Type PROCEDURE

Other Intervention Names

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remote ischemic preconditioning RIPC

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xijing Hospital, Fourth Military Medical University

Principal Investigators

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Hailong DONG, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Other Identifiers

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DONG2008RPC

Identifier Type: -

Identifier Source: org_study_id