NCT05895331

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 31, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

May 31, 2023

Last Update Submit

June 7, 2023

Conditions

DexmedetomidineOxidative Stress

Keywords

DisulphideThiol

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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

Interventions

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).

Dexmedetomidine non-used group in Coronary Bypass SurgeryDexmedetomidine used group in Coronary Bypass Surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undergone coronary bypass surgery using a cardiopulmonary pump

You may qualify if:

  • Patients who have undergone coronary bypass surgery using a cardiopulmonary pump
  • Patients who agreed to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 25304913BACKGROUND

  • 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.

    PMID: 29436236BACKGROUND

  • 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.

    PMID: 34381560BACKGROUND

  • 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.

    PMID: 34561931BACKGROUND

  • Ozguner 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.

    PMID: 39511476DERIVED

Central Study Contacts

Yusuf Ozguner

CONTACT

+905427150725y.ozguner@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 8, 2023

Study Start

June 5, 2023

Primary Completion

September 5, 2023

Study Completion

October 5, 2023

Last Updated

June 9, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)