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Completed

NCT Number: NCT00866489

The Neuroprotective Effects of RPC on the Neurosurgery

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

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Key information

Conditions

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

remote preconditioning

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.

Other names: remote ischemic preconditioning, RIPC

Primary outcomes

  1. S-100b and NSE level

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Clinical Trial Cencer, Xijing Hospital, Fourth Military Medical University

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 20, 2009
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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