The Neuroprotective Effects of RPC on the Neurosurgery
|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|
- S-100b and NSE level [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
No Intervention: sham RIPC
Patients had a deflated cuff placed on the right upper arm for 30 min.
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.
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.
In patients undergoing elective craniotomy for supratentorial meningioma, RIPC reduces the incidence of postoperative cerebral injury.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866489
|Principal Investigator:||Hailong DONG, M.D.,Ph.D.||Xijing Hospital|