Back to resultsEffect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations
Primary Purpose
Arthroplasty, Replacement
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Arthroplasty, Replacement
Eligibility Criteria
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
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Dexmedetomidine group
Arm Description
The control group received saline instead of dexmedetomidine.
The dexmedetomidine group received the dexmedetomidine.
Outcomes
Primary Outcome Measures
changes of malondialdehyde (μmol/L)
Secondary Outcome Measures
changes of interleukin-6 (pg/ml)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02648958
Brief Title
Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations
Official Title
Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Unilateral Total Knee Replacement - a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The control group received saline instead of dexmedetomidine.
Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
The dexmedetomidine group received the dexmedetomidine.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
The control group received the normal saline infusion
Primary Outcome Measure Information:
Title
changes of malondialdehyde (μmol/L)
Time Frame
up to 1 day
Secondary Outcome Measure Information:
Title
changes of interleukin-6 (pg/ml)
Time Frame
up to 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YONGSEON CHOI
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations
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