NCT02648958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

June 13, 2018

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

December 6, 2015

Last Update Submit

June 12, 2018

Conditions

Arthroplasty, Replacement

Outcome Measures

Primary Outcomes (1)

  • changes of malondialdehyde (μmol/L)

    up to 1 day

Secondary Outcomes (1)

  • changes of interleukin-6 (pg/ml)

    up to 1 day

Study Arms (2)

Control group

PLACEBO COMPARATOR

The control group received saline instead of dexmedetomidine.

Drug: normal saline

Dexmedetomidine group

EXPERIMENTAL

The dexmedetomidine group received the dexmedetomidine.

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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.

Also known as: precedex
Dexmedetomidine group
normal salineDRUG

The control group received the normal saline infusion

Control group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society Anesthesiologists classification I-III

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • YONGSEON CHOI

    Assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2015

First Posted

January 7, 2016

Study Start

January 1, 2016

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

June 13, 2018

Record last verified: 2016-01

Locations

KR(1)