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Completed

NCT Number: NCT00778323

Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

limb remote ischemic preconditioning (LRIPC)

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.

Other names: an automated cuff-inflator made in China

Primary outcomes

  1. serum concentrations of s-100B,NSE

    Time frame: 1 week or more

Secondary outcomes

  1. a Japanese Orthopaedic Association (JOA) scale

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Oct 23, 2008
Registry last updated
Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.