Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

Study Overview
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Brief Summary
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The purpose of this study is to assess whether a large clinical trial testing the effect of RIPC on neurologic outcome in patients undergoing elective cervical decompression surge is warranted.

Detailed Description
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Spinal cord ischemia-reperfusion injury commonly contribute to perioperative morbidity and mortality after elective cervical decompression surgery.Remote ischemic preconditioning(RIPC)is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide system protection from prolonged ischemia.The hypothesis of this protocol is that limb ischemic preconditioning could reduces spinal cord ischemia-reperfusion injury induced by elective cervical decompression surgery.Serum s-100B and NSE concentration will be measured before and after induction ,and at 6 hours,1,3,5 and 7days after surgery.JOA scores in all the cases will be evaluated before operation and at 7days ,1,3,6 month after surgery.

Official Title
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Effects of Remote Ischemic Preconditioning on Biochemical Markers and Neurological Outcomes in Patients Undergoing Elective Cervical Decompression Surgery

Conditions
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Cervical Compression Myelopathy, Ischemia, Reperfusion Injury, Spinal Cord Injury

Intervention / Treatment
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* Procedure: limb remote ischemic preconditioning (LRIPC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical and radiological signs of cervical compression myelopathy(ccm) Age 30-75 Stage 1-2 Exclusion Criteria: Age>75 History of heart,hepatic,renal or pulmonary disease. History of peripheral vascular disease affecting the upper limbs.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A,2, II<br> | Procedure: limb remote ischemic preconditioning (LRIPC)<br>* LRIPC consists of three 5-min cycles of right upper limb ischemia induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mmHg,with an intervening 5 min reperfusion during which the cuff is deflated.<br>* Other names: an automated cuff-inflator made in China;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum concentrations of s-100B,NSE |  | 1 week or more | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a Japanese Orthopaedic Association (JOA) scale |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord, remote ischemic preconditioning, cervical compression myelopathy, neuron-specific enolase, s-100B