Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778323
• Other study ID #: XJ20070901
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 9, 2008
• Last updated: February 24, 2011
• Start date: September 2007
• Est. completion date: April 2009

Study information

• Verified date: November 2008
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Compression Myelopathy
• Ischemia
• Reperfusion Injury
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum concentrations of s-100B,NSE		1 week or more	No
Secondary	a Japanese Orthopaedic Association (JOA) scale		6 months	No