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Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

Primary Purpose

Cervical Compression Myelopathy, Ischemia, Reperfusion Injury

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

limb remote ischemic preconditioning (LRIPC)

About this trial

This is an interventional prevention trial for Cervical Compression Myelopathy focused on measuring remote ischemic preconditioning, cervical compression myelopathy, spinal cord, neuron-specific enolase, s-100B

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Xijing Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A,2, II

Arm Description

Outcomes

Primary Outcome Measures

serum concentrations of s-100B,NSE

Secondary Outcome Measures

a Japanese Orthopaedic Association (JOA) scale

Full Information

NCT ID

NCT00778323

First Posted

August 9, 2008

Last Updated

February 24, 2011

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00778323

Brief Title

Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

remote ischemic preconditioning, cervical compression myelopathy, spinal cord, neuron-specific enolase, s-100B

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A,2, II

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

limb remote ischemic preconditioning (LRIPC)

Other Intervention Name(s)

an automated cuff-inflator made in China

Intervention Description

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.

Primary Outcome Measure Information:

Title

serum concentrations of s-100B,NSE

Time Frame

1 week or more

Secondary Outcome Measure Information:

Title

a Japanese Orthopaedic Association (JOA) scale

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lize Xiong, MD

Organizational Affiliation

Xiling Hospital,Fourth Military Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Xijing Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

19996767

Citation

Hu S, Dong HL, Li YZ, Luo ZJ, Sun L, Yang QZ, Yang LF, Xiong L. Effects of remote ischemic preconditioning on biochemical markers and neurologic outcomes in patients undergoing elective cervical decompression surgery: a prospective randomized controlled trial. J Neurosurg Anesthesiol. 2010 Jan;22(1):46-52. doi: 10.1097/ANA.0b013e3181c572bd. Erratum In: J Neurosurg Anesthesiol. 2010 Apr;22(2):157.

Results Reference

derived

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Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

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