DexmedetomidineNCT05895331
The Effects of Dexmedetomidine on Thiol/Disulphide Homeostasis in Coronary Bypass Surgery
An observational study of Dexmedetomidine and Oxidative Stress, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Dexmedetomidine (DEX) is a sedative and anesthetic drug with known antioxidant properties.In this study, it was aimed to investigate the oxidative stress levels in patients undergoing on-pump CABG by measuring the thiol/disulfide levels and to investigate the effects of dexmedetomidine infusion used in Coronary Bypass… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dexmedetomidine, Oxidative Stress
- What is being tested?
- Thiol/Disulphide Homeostasis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2023to 5 Oct 2023
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone coronary bypass surgery using a cardiopulmonary pump
Who may be able to join
- Patients who have undergone coronary bypass surgery using a cardiopulmonary pump
- Patients who agreed to participate in the study
Who cannot join
- Bypass surgeries without cardiopulmonary pump
- Patients with intraoperative unexpected/undesirable complications
- Patients who did not agree to participate in the study
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170
Yusuf Ozguner, +903127970000, etliksh.iletisim@saglik.gov.tr
About this study
Dexmedetomidine (DEX) is a sedative and anesthetic drug with known antioxidant properties.In this study, it was aimed to investigate the oxidative stress levels in patients undergoing on-pump CABG by measuring the thiol/disulfide levels and to investigate the effects of dexmedetomidine infusion used in Coronary Bypass Surgery on dynamic Thiol/Disulphide Homeostasis.
Read the detailed description
It is well known that cardiovascular disease is the leading cause of increased morbidity and mortality worldwide. One of the key surgical procedures that patients with coronary artery disease (CAD) are often subjected to is coronary artery bypass grafting (CABG). However, the cardiopulmonary bypass (CPB) pump increases systemic oxidative stress . High levels of molecular oxygen enter the body during cardiopulmonary bypass (CPB) and reperfusion, followed by inflammation leading to the formation of free oxygen radicals which causes lipid peroxidation, ultimately resulting in an oxidative attack at the cell and tissue level.
Thiols are organic sulphur derivatives containing Sulfhydryl Residues (-SH) in their active regions. Thiols easily react with oxygen containing free radicals to form disulfides. This is a defence mechanism against oxidative stress.7 An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).The role of dynamic thioldisulfide homeostasis has been increasingly shown in many diseases. There is a growing number of evidences that an abnormal thiol-disulfide homeostasis may play role in the pathogenesis of a variety of diseases such as cardiovascular disease, malignancies, rheumatoid arthritis, chronic kidney disease, and acquired immunodeficiency syndrome.
Dexmedetomidine (DEX) is a sedative and anesthetic drug with known antioxidant properties.In this study, it was aimed to investigate the oxidative stress levels in patients undergoing on-pump CABG by measuring the thiol/disulfide levels and to investigate the effects of dexmedetomidine infusion used in Coronary Bypass Surgery on dynamic Thiol/Disulphide Homeostasis.
- Conditions
- Dexmedetomidine, Oxidative Stress
- Being tested
- Thiol/Disulphide Homeostasis
- Keywords
- Disulphide, Thiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiol/Disulphide HomeostasisDiagnostic test
An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine used group in Coronary Bypass Surgery | Not described Receives: Diagnostic Test: Thiol/Disulphide Homeostasis | |
| Dexmedetomidine non-used group in Coronary Bypass Surgery | Not described Receives: Diagnostic Test: Thiol/Disulphide Homeostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thiol/Disulphide Homeostasis
An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).
Measured: 30 min before the start of surgery
Thiol/Disulphide Homeostasis
An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).
Measured: at the time of aortic cross clamp off
Thiol/Disulphide Homeostasis
An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).
Measured: at the time of surgery over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start5 Jun 2023 (estimated)
- Primary completion5 Sep 2023 (estimated)
- Study completion5 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Özgüner, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895331
- Sponsor's protocol ID
- AnkaraEtlikYusufOzguner001
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erel O, Neselioglu S. A novel and automated assay for thiol/disulphide homeostasis. Clin Biochem. 2014 Dec;47(18):326-32. doi: 10.1016/j.clinbiochem.2014.09.026. Epub 2014 Oct 7.
PubMed 25304913Akkus O, Kaypakli O, Koca H, Topuz M, Kaplan M, Baykan AO, Samsa MZ, Quisi A, Erel O, Neselioglu S, Gur M. Thiol/disulphide homeostasis in thoracic aortic aneurysm and acute aortic syndrome. Biomark Med. 2018 Apr;12(4):349-358. doi: 10.2217/bmm-2017-0372. Epub 2018 Feb 13.
PubMed 29436236Vukicevic P, Klisic A, Neskovic V, Babic L, Mikic A, Bogavac-Stanojevic N, Matkovic M, Milicevic V, Aleksic N, Kotur-Stevuljevic J. Oxidative Stress in Patients before and after On-Pump and Off-Pump Coronary Artery Bypass Grafting: Relationship with Syntax Score. Oxid Med Cell Longev. 2021 Jul 30;2021:3315951. doi: 10.1155/2021/3315951. eCollection 2021.
PubMed 34381560Unchiti K, Leurcharusmee P, Samerchua A, Pipanmekaporn T, Chattipakorn N, Chattipakorn SC. The potential role of dexmedetomidine on neuroprotection and its possible mechanisms: Evidence from in vitro and in vivo studies. Eur J Neurosci. 2021 Nov;54(9):7006-7047. doi: 10.1111/ejn.15474. Epub 2021 Oct 25.
PubMed 34561931Ozguner Y, Altinsoy S, Kulturoglu G, Unal D, Ergil J, Neselioglu S, Erel O. The effects of dexmedetomidine on thiol/disulphide homeostasis in coronary artery bypass surgery: a randomized controlled trial. BMC Anesthesiol. 2024 Nov 7;24(1):402. doi: 10.1186/s12871-024-02794-1.
PubMed 39511476
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine on Thiol/Disulphide Homeostasis in Coronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT05895331
- Acronym / sponsor ID
- AnkaraEtlikYusufOzguner001
- Conditions
- Dexmedetomidine, Oxidative Stress
- Keywords
- Disulphide, Thiol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 5 Jun 2023 (estimated)
- Primary completion
- 5 Sep 2023 (estimated)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 8 Jun 2023 (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.
Dexmedetomidine (DEX) is a sedative and anesthetic drug with known antioxidant properties.In this study, it was aimed to investigate the oxidative stress levels in patients undergoing on-pump CABG by measuring the thiol/disulfide levels and to investigate the effects of dexmedetomidine infusion used in Coronary Bypass Surgery on dynamic Thiol/Disulphide Homeostasis.
Detailed description
It is well known that cardiovascular disease is the leading cause of increased morbidity and mortality worldwide. One of the key surgical procedures that patients with coronary artery disease (CAD) are often subjected to is coronary artery bypass grafting (CABG). However, the cardiopulmonary bypass (CPB) pump increases systemic oxidative stress . High levels of molecular oxygen enter the body during cardiopulmonary bypass (CPB) and reperfusion, followed by inflammation leading to the formation of free oxygen radicals which causes lipid peroxidation, ultimately resulting in an oxidative attack at the cell and tissue level.
Thiols are organic sulphur derivatives containing Sulfhydryl Residues (-SH) in their active regions. Thiols easily react with oxygen containing free radicals to form disulfides. This is a defence mechanism against oxidative stress.7 An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).The role of dynamic thioldisulfide homeostasis has been increasingly shown in many diseases. There is a growing number of evidences that an abnormal thiol-disulfide homeostasis may play role in the pathogenesis of a variety of diseases such as cardiovascular disease, malignancies, rheumatoid arthritis, chronic kidney disease, and acquired immunodeficiency syndrome.
Dexmedetomidine (DEX) is a sedative and anesthetic drug with known antioxidant properties.In this study, it was aimed to investigate the oxidative stress levels in patients undergoing on-pump CABG by measuring the thiol/disulfide levels and to investigate the effects of dexmedetomidine infusion used in Coronary Bypass Surgery on dynamic Thiol/Disulphide Homeostasis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine used group in Coronary Bypass Surgery | – | Diagnostic Test: Thiol/Disulphide Homeostasis |
| Dexmedetomidine non-used group in Coronary Bypass Surgery | – | Diagnostic Test: Thiol/Disulphide Homeostasis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone coronary bypass surgery using a cardiopulmonary pump
Key inclusion criteria (2 listed)
- Patients who have undergone coronary bypass surgery using a cardiopulmonary pump
- Patients who agreed to participate in the study
Key exclusion criteria (4 listed)
- Bypass surgeries without cardiopulmonary pump
- Patients with intraoperative unexpected/undesirable complications
- Patients who did not agree to participate in the study
- Patients with missing data
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 |
|---|---|---|
| Thiol/Disulphide HomeostasisAn automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH). | Diagnostic test | Dexmedetomidine non-used group in Coronary Bypass Surgery, Dexmedetomidine used group in Coronary Bypass Surgery |
Primary outcome
Thiol/Disulphide Homeostasis
Time frame: 30 min before the start of surgery
An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).
Thiol/Disulphide Homeostasis
Time frame: at the time of aortic cross clamp off
An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).
Thiol/Disulphide Homeostasis
Time frame: at the time of surgery over
An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 25304913Erel O, Neselioglu S. A novel and automated assay for thiol/disulphide homeostasis. Clin Biochem. 2014 Dec;47(18):326-32. doi: 10.1016/j.clinbiochem.2014.09.026. Epub 2014 Oct 7.
- Background: PubMed 29436236Akkus O, Kaypakli O, Koca H, Topuz M, Kaplan M, Baykan AO, Samsa MZ, Quisi A, Erel O, Neselioglu S, Gur M. Thiol/disulphide homeostasis in thoracic aortic aneurysm and acute aortic syndrome. Biomark Med. 2018 Apr;12(4):349-358. doi: 10.2217/bmm-2017-0372. Epub 2018 Feb 13.
- Background: PubMed 34381560Vukicevic P, Klisic A, Neskovic V, Babic L, Mikic A, Bogavac-Stanojevic N, Matkovic M, Milicevic V, Aleksic N, Kotur-Stevuljevic J. Oxidative Stress in Patients before and after On-Pump and Off-Pump Coronary Artery Bypass Grafting: Relationship with Syntax Score. Oxid Med Cell Longev. 2021 Jul 30;2021:3315951. doi: 10.1155/2021/3315951. eCollection 2021.
- Background: PubMed 34561931Unchiti K, Leurcharusmee P, Samerchua A, Pipanmekaporn T, Chattipakorn N, Chattipakorn SC. The potential role of dexmedetomidine on neuroprotection and its possible mechanisms: Evidence from in vitro and in vivo studies. Eur J Neurosci. 2021 Nov;54(9):7006-7047. doi: 10.1111/ejn.15474. Epub 2021 Oct 25.
- Derived from this study: PubMed 39511476Ozguner Y, Altinsoy S, Kulturoglu G, Unal D, Ergil J, Neselioglu S, Erel O. The effects of dexmedetomidine on thiol/disulphide homeostasis in coronary artery bypass surgery: a randomized controlled trial. BMC Anesthesiol. 2024 Nov 7;24(1):402. doi: 10.1186/s12871-024-02794-1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dexmedetomidine and Oxidative Stress, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. 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 Turkey (Türkiye). 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yusuf Ozguner (+905427150725, y.ozguner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thiol/Disulphide Homeostasis (time frame: 30 min before the start of surgery). The study lists 3 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 NCT05895331, which also lists 5 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 9 Jun 2023.