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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05895331
Other study ID # AnkaraEtlikYusufOzguner001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 5, 2023
Est. completion date October 5, 2023

Study information

Verified date June 2023
Source Ankara Etlik City Hospital
Contact Yusuf Ozguner
Phone +905427150725
Email y.ozguner@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 Surgery on dynamic Thiol/Disulphide Homeostasis.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date October 5, 2023
Est. primary completion date September 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients who have undergone coronary bypass surgery using a cardiopulmonary pump - Patients who agreed to participate in the study Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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).

Locations

Country Name City State
Turkey Ankara Etlik City Hospital Ankara Varlik Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle

Sponsors (1)

Lead Sponsor Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Akkus 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. — View Citation

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. — View Citation

Unchiti 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. — View Citation

Vukicevic 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 30 min before the start of surgery
Primary 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). at the time of aortic cross clamp off
Primary 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). at the time of surgery over
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