Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

Phase 1

Completed

• Conditions: Cervical Compression Myelopathy; Ischemia; Reperfusion Injury; Spinal Cord Injury
• Interventions: Procedure: limb remote ischemic preconditioning (LRIPC)

• Registration Number: NCT00778323
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-08-09
• Primary Completion: 2008-10
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-23
• Status Verified: 2008-11
• Study Completion: 2009-04
• Last Update Submitted: 2011-02-24
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A,2, II	limb remote ischemic preconditioning (LRIPC)	-

Primary Outcome Measures

Name	Time	Method
serum concentrations of s-100B,NSE	1 week or more

Secondary Outcome Measures

Name	Time	Method
a Japanese Orthopaedic Association (JOA) scale	6 months

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China