The Effects of Dexmedetomidine on Thiol/Disulphide Homeostasis in Coronary Bypass Surgery

June 7, 2023 updated by: Yusuf Özgüner, Ankara Etlik City Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
      • Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey, 06170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone coronary bypass surgery using a cardiopulmonary pump

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Dexmedetomidine used group in Coronary Bypass Surgery
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).
Dexmedetomidine non-used group in Coronary Bypass Surgery
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
30 min before the start of surgery
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).
at the time of aortic cross clamp off
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).
at the time of surgery over

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Etlik City Hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AnkaraEtlikYusufOzguner001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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