Arthroplasty, ReplacementNCT02648958
Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations
A study testing Dexmedetomidine and normal saline in people with Arthroplasty, Replacement, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement
- What is being tested?
- Dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society Anesthesiologists classification I-III
Who cannot join
- use of antioxidants clinically significant cardiovascular, renal, or hepatic diseases heart block greater than the first degree
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Unilateral Total Knee Replacement - a Randomized, Controlled Trial
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.
- Conditions
- Arthroplasty, Replacement
- Being tested
- Dexmedetomidine, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
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 salineDrug
The control group received the normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The control group received saline instead of dexmedetomidine. Receives: Drug: normal saline |
| Dexmedetomidine group | Experimental | The dexmedetomidine group received the dexmedetomidine. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of malondialdehyde (μmol/L)
Measured: up to 1 day
Secondary outcomes (1)
changes of interleukin-6 (pg/ml)
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, ReplacementStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YONGSEON CHOI, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648958
- Sponsor's protocol ID
- 4-2015-0794
- Status last verified
- Jan 2016
- First submitted
- 6 Dec 2015
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Unilateral Total Knee Replacement - a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02648958
- Acronym / sponsor ID
- 4-2015-0794
- Conditions
- Arthroplasty, Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: normal salineThe control group received saline instead of dexmedetomidine. |
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineThe dexmedetomidine group received the dexmedetomidine. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society Anesthesiologists classification I-III
Key exclusion criteria (1 listed)
- use of antioxidants clinically significant cardiovascular, renal, or hepatic diseases heart block greater than the first degree
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: precedexThe 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. | Drug | Dexmedetomidine group |
| normal salineThe control group received the normal saline infusion | Drug | Control group |
Primary outcome
changes of malondialdehyde (μmol/L)
Time frame: up to 1 day
1 secondary outcome
changes of interleukin-6 (pg/ml)
Time frame: up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YONGSEON CHOI principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and normal saline in people with Arthroplasty, Replacement, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of malondialdehyde (μmol/L) (time frame: up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.