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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
History of Changes

March 19, 2009
December 26, 2010
September 2008
June 2009   (final data collection date for primary outcome measure)
S-100b and NSE level [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
S-100b and NSE level [ Time Frame: 72 HOURS ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00866489 on ClinicalTrials.gov Archive Site
 
 
 
 
 
The Neuroprotective Effects of RPC on the Neurosurgery
Clinical Trial Cencer, Xijing Hospital, Fourth Military Medical University

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

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
s100b
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
  • 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
    Intervention: Procedure: remote preconditioning
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00866489
DONG2008RPC
Yes
Hailong Dong, Xijing Hospital, Fourth Military Medical University
Xijing Hospital
 
Principal Investigator: Hailong DONG, M.D.,Ph.D. Xijing Hospital
Xijing Hospital
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP