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

NCT ID: NCT02648958

Last Updated: 2018-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty, Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control group

The control group received saline instead of dexmedetomidine.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

The control group received the normal saline infusion

Dexmedetomidine group

The dexmedetomidine group received the dexmedetomidine.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

normal saline

The control group received the normal saline infusion

Intervention Type DRUG

Other Intervention Names

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precedex

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YONGSEON CHOI

Role: PRINCIPAL_INVESTIGATOR

Assistant professor

Locations

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Severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2015-0794

Identifier Type: -

Identifier Source: org_study_id

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