Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

NCT ID: NCT00778323

Last Updated: 2011-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-04-30

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.

Conditions

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Cervical Compression Myelopathy Ischemia Reperfusion Injury Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A,2, II

Group Type EXPERIMENTAL

limb remote ischemic preconditioning (LRIPC)

Intervention Type PROCEDURE

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.

Interventions

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limb remote ischemic preconditioning (LRIPC)

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.

Intervention Type PROCEDURE

Other Intervention Names

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an automated cuff-inflator made in China

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fourth Military Medical University

Principal Investigators

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Lize Xiong, MD

Role: STUDY_CHAIR

Xiling Hospital,Fourth Military Medical University

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 19996767 (View on PubMed)

Other Identifiers

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XJ20070901

Identifier Type: -

Identifier Source: org_study_id

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