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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02648958
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement Drug: Dexmedetomidine Drug: normal saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Unilateral Total Knee Replacement - a Randomized, Controlled Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control group
The control group received saline instead of dexmedetomidine.
 Drug: normal saline
The control group received the normal saline infusion
Experimental: Dexmedetomidine group
The dexmedetomidine group received the dexmedetomidine.
 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.
Other Name: precedex


Outcome Measures
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Primary Outcome Measures :
  1. changes of malondialdehyde (μmol/L) [ Time Frame: up to 1 day ]

Secondary Outcome Measures :
  1. changes of interleukin-6 (pg/ml) [ Time Frame: up to 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648958


Locations
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Korea, Republic of
Severance hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: YONGSEON CHOI Assistant professor
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02648958    
Other Study ID Numbers: 4-2015-0794
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: January 2016
Additional relevant MeSH terms:
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Reperfusion Injury
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action