GonarthrosisPhase 4NCT07875231
Dexmedetomidine Infusion and Iscemia and Reperfusion Injury
A Phase 4 study testing Dexmedetomidine and saline in people with Gonarthrosis, run by Diskapi Yildirim Beyazit Education and Research Hospital.
Trial summary
The effect of deksmedetomidine infusion on ischemia-reperfusion injury related to tourniquet application during total knee replacement will be evaluated by malondialdehyde and total antioksidant status. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- Dexmedetomidine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Apr 2016
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA1-3 patients
Who cannot join
- ASA 4-5 patients, antioksidant drug use, contrandication for spinal anesthesia
About this study
Official title: The Effect of Dexmedetomidine Infusion on Turniquet Induced Iscemia and Reperfusion Injury in Total Knee Replacement Surgery
The effect of deksmedetomidine infusion on ischemia-reperfusion injury related to tourniquet application during total knee replacement will be evaluated by malondialdehyde and total antioksidant status.
Read the detailed description
Spinal anestesia will be performed to patients undergoing total knee replacement . A continuos infusion (0.1 micg/kg/min for 10 minutes followed by 0.2-0.7 micg/kg/hr) of deksmedetomidine will be used until the end of the surgery in the Deksmedetomidine group, an equivalent volume of salin will be delivered to the saline group. The venous blood sample will be obtained before spinal anestesia, and 1 minute before tourniquet inflation and 15 minutes after tourniquet deflation to determine malondialdehyde and total anti-oksidant status.
- Conditions
- Gonarthrosis
- Being tested
- Dexmedetomidine, saline
- Keywords
- deksmedetomidine, iscemia reperfusion injury, total knee replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
0.1 mcg/kg/min 10 minutes dexmedetomidine infusion followed by 0.2-0.7 mcg/kg/hour dexmedetomidine infusion
salineDrug
0.1 mcg/kg/min 10 minutes saline infusion followed by 0.2-0.7 mcg/kg/hour saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 0.1 mcg/kg/min 10 minutes dexmedetomidine infusion followed by 0.2-0.7 mcg/kg/hour dexmedetomidine infusion Receives: Drug: Dexmedetomidine |
| saline | Active comparator | 0.1 mcg/kg/min 10 minutes saline infusion followed by 0.2-0.7 mcg/kg/hour saline infusion Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood malondialdehide levels
5 minutes before commencing spinal aneashesia
Measured: 5 minutes before commencing spinal aneashesia
blood malondialdehide levels
1 minute before turniquet deflation
Measured: 1 minute before turniquet deflation
blood malondialdehide levels
15 minutes after turniquet deflation
Measured: 15 minutes after turniquet deflation
blood total antioksidant status
5 minutes before commencing spinal aneashesia
Measured: 5 minutes before commencing spinal aneashesia
blood total antioksidant status
1 minute before turniquet deflation
Measured: 1 minute before turniquet deflation
blood total antioksidant status
15 minutes after turniquet deflation
Measured: 15 minutes after turniquet deflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startDec 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeynep Koc, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Murat Sayın, Assoc. Prof., Study chair, Dışkapı Yıldırım Beyazıt E.A.H.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875231
- Sponsor's protocol ID
- Dıskapı YBERH
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2015
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yagmurdur H, Ozcan N, Dokumaci F, Kilinc K, Yilmaz F, Basar H. Dexmedetomidine reduces the ischemia-reperfusion injury markers during upper extremity surgery with tourniquet. J Hand Surg Am. 2008 Jul-Aug;33(6):941-7. doi: 10.1016/j.jhsa.2008.01.014.
PubMed 18656769Koruk S, Mizrak A, Kaya R, Ugur B, Cebesoy O, Celik A, Oner U. The effects of dexmedetomidine on ischemia reperfusion injury in patients undergoing arthroscopy under spinal anesthesia. Eurasian J Med. 2010 Dec;42(3):137-41. doi: 10.5152/eajm.2010.38.
PubMed 25610144
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine Infusion on Turniquet Induced Iscemia and Reperfusion Injury in Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT07875231
- Acronym / sponsor ID
- Dıskapı YBERH
- Conditions
- Gonarthrosis
- Keywords
- deksmedetomidine, iscemia reperfusion injury, total knee replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- Dec 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Oct 2026 (actual)
- 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.
The effect of deksmedetomidine infusion on ischemia-reperfusion injury related to tourniquet application during total knee replacement will be evaluated by malondialdehyde and total antioksidant status.
Detailed description
Spinal anestesia will be performed to patients undergoing total knee replacement . A continuos infusion (0.1 micg/kg/min for 10 minutes followed by 0.2-0.7 micg/kg/hr) of deksmedetomidine will be used until the end of the surgery in the Deksmedetomidine group, an equivalent volume of salin will be delivered to the saline group. The venous blood sample will be obtained before spinal anestesia, and 1 minute before tourniquet inflation and 15 minutes after tourniquet deflation to determine malondialdehyde and total anti-oksidant status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine0.1 mcg/kg/min 10 minutes dexmedetomidine infusion followed by 0.2-0.7 mcg/kg/hour dexmedetomidine infusion |
| saline | Active comparator | Drug: saline0.1 mcg/kg/min 10 minutes saline infusion followed by 0.2-0.7 mcg/kg/hour saline infusion |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA1-3 patients
Key exclusion criteria (1 listed)
- ASA 4-5 patients, antioksidant drug use, contrandication for spinal anesthesia
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: precedex0.1 mcg/kg/min 10 minutes dexmedetomidine infusion followed by 0.2-0.7 mcg/kg/hour dexmedetomidine infusion | Drug | Dexmedetomidine |
| saline0.1 mcg/kg/min 10 minutes saline infusion followed by 0.2-0.7 mcg/kg/hour saline infusion | Drug | saline |
Primary outcome
blood malondialdehide levels
Time frame: 5 minutes before commencing spinal aneashesia
5 minutes before commencing spinal aneashesia
blood malondialdehide levels
Time frame: 1 minute before turniquet deflation
1 minute before turniquet deflation
blood malondialdehide levels
Time frame: 15 minutes after turniquet deflation
15 minutes after turniquet deflation
blood total antioksidant status
Time frame: 5 minutes before commencing spinal aneashesia
5 minutes before commencing spinal aneashesia
blood total antioksidant status
Time frame: 1 minute before turniquet deflation
1 minute before turniquet deflation
blood total antioksidant status
Time frame: 15 minutes after turniquet deflation
15 minutes after turniquet deflation
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 15 Oct 2026.
- Results publication: PubMed 18656769Yagmurdur H, Ozcan N, Dokumaci F, Kilinc K, Yilmaz F, Basar H. Dexmedetomidine reduces the ischemia-reperfusion injury markers during upper extremity surgery with tourniquet. J Hand Surg Am. 2008 Jul-Aug;33(6):941-7. doi: 10.1016/j.jhsa.2008.01.014.
- Results publication: PubMed 25610144Koruk S, Mizrak A, Kaya R, Ugur B, Cebesoy O, Celik A, Oner U. The effects of dexmedetomidine on ischemia reperfusion injury in patients undergoing arthroscopy under spinal anesthesia. Eurasian J Med. 2010 Dec;42(3):137-41. doi: 10.5152/eajm.2010.38.
- Individual participant dataSharing planned: No
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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.
Murat Sayın, Assoc. Prof. study chair
Dışkapı Yıldırım Beyazıt E.A.H.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and saline in people with Gonarthrosis, run by Diskapi Yildirim Beyazit Education and Research Hospital.
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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
blood malondialdehide levels (time frame: 5 minutes before commencing spinal aneashesia). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07875231, which also lists 2 linked publications.
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 15 Oct 2026.