The Neuroprotective Effects of RPC on the Neurosurgery

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00866489
First received: March 19, 2009
Last updated: December 26, 2010
Last verified: March 2009
  Purpose

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


Condition Intervention Phase
s100b
Procedure: remote preconditioning
Phase 1

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: Clinical Trial Cencer, Xijing Hospital, Fourth Military Medical University

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • S-100b and NSE level [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: sham RIPC
Patients had a deflated cuff placed on the right upper arm for 30 min.
Experimental: 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
Procedure: 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.
Other Names:
  • remote ischemic preconditioning
  • RIPC

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00866489

Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Hailong DONG, M.D.,Ph.D. Xijing Hospital
  More Information

No publications provided

Responsible Party: Hailong Dong, Xijing Hospital, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT00866489     History of Changes
Other Study ID Numbers: DONG2008RPC
Study First Received: March 19, 2009
Last Updated: December 26, 2010
Health Authority: China: National Natural Science Foundation
China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Experimental

ClinicalTrials.gov processed this record on September 14, 2014