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NCT02648958 Clinical Trial

Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations

Arthroplasty, Replacement Clinical Trial

Official title:
Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Unilateral Total Knee Replacement - a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02648958
Other study ID # 4-2015-0794
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date July 31, 2017

Study information
Verified date January 2016
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ischemia reperfusion injury causes the release of free oxygen radicals. The selective alpha2-receptor agonist, dexmedetomidine, has an inhibitory effect on inflammatory responses during ischemic injury. The aim of this study is to evaluate the effect of dexmedetomidine on inflammatory responses during ischemia-reperfusion injury in skeletal muscle.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date July 31, 2017
Est. primary completion date July 31, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- American Society Anesthesiologists classification I-III

Exclusion Criteria:

- use of antioxidants clinically significant cardiovascular, renal, or hepatic diseases heart block greater than the first degree

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
The dexmedetomidine group received the dexmedetomidine infusion at a rate of 0.4mg/kg/h after a loading dose of 0.5mg/kg for 10 minutes.
• normal saline
The control group received the normal saline infusion

Locations
Country Name City State
Korea, Republic of Severance hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary changes of malondialdehyde (µmol/L) up to 1 day
Secondary changes of interleukin-6 (pg/ml) up to 1 day
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