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Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

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ClinicalTrials.gov Identifier: NCT00778323
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : February 25, 2011
Sponsor:
Information provided by:
Xijing Hospital

August 9, 2008
October 23, 2008
February 25, 2011
September 2007
October 2008   (Final data collection date for primary outcome measure)
serum concentrations of s-100B,NSE [ Time Frame: 1 week or more ]
serum concentrations of s-100b,NSE,MDA and SOD [ Time Frame: 1 week or more ]
Complete list of historical versions of study NCT00778323 on ClinicalTrials.gov Archive Site
a Japanese Orthopaedic Association (JOA) scale [ Time Frame: 6 months ]
a modified Japanese Orthopaedic Association (mJOA) scale [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery
Effects of Remote Ischemic Preconditioning on Biochemical Markers and Neurological Outcomes in Patients Undergoing Elective 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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
  • Cervical Compression Myelopathy
  • Ischemia
  • Reperfusion Injury
  • Spinal Cord Injury
Procedure: 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.
Other Name: an automated cuff-inflator made in China
Experimental: A,2, II
Intervention: Procedure: limb remote ischemic preconditioning (LRIPC)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
60
April 2009
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00778323
XJ20070901
Yes
Not Provided
Not Provided
Lize Xiong, Fourth Military Medical University
Xijing Hospital
Not Provided
Study Chair: Lize Xiong, MD Xiling Hospital,Fourth Military Medical University
Xijing Hospital
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP