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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00778323
Enrollment
51
Registered
2008-10-23
Start date
2007-09-30
Completion date
2009-04-30
Last updated
2011-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

PROCEDURElimb 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.

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
serum concentrations of s-100B,NSE1 week or more

Secondary

MeasureTime frame
a Japanese Orthopaedic Association (JOA) scale6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026