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Completed

NCT Number: NCT06209437

Anesthesia Management of Coronary Artery Bypass Surgery and Inflammatory Biomarkers

The goal of this observational study is to evaluate effect of total intravenous anesthesia or inhalation anesthesia on inflammatory biomarkers in coronary artery bypass surgery and their relationship with early postoperative complications. The main questions it aims to answer are

* Does the type of anesthesia have a relationship with inflammatory biomarkers? * Are inflammatory biomarkers associated with postoperative complications?

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Key information

Conditions

Coronary Artery Disease Anesthesia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara city hospital bilkent

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

This study is planned to be a prospective observational clinical study. Patients who will undergo on-pump coronary artery bypass surgery, meet the eligibility criteria and agree to participate in the study and sign the informed patient consent form will be included in the study.Systemic immune inflammatory index, systemic inflammatory response index, neurophile lymphocyte ratio, platelet lymphocyte ratio will be calculated in the routine complete blood count of patients in the last 3 preoperative days and in the first 24 hours postoperatively.It will be evaluated whether these biomarkers are related to the anesthesia technique used, patients comorbidities and the complications that develop in the first 24 hours postoperatively. Patients will be evaluated preoperatively, intraoperatively and postoperatively; preoperative comorbidities, intraoperative anesthesia management, cross clamp, pump and surgery times, blood and blood product transfusion, inotrope use and complications that develop up to the first 24 hours postoperatively will be recorded.The anesthetic technique to be used will be determined according to the anesthesiologist's preference and will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • On-pump bypass surgery
  • Del-Nido cardioplegia used in operation
  • ASA (American Society of Anesthesiologists) II- III patients

Exclusion criteria

  • Patients with active malignancy
  • Diagnosed with systemic inflammatory disease or autoimmune disease
  • Chronic liver and kidney disease
  • History of cerebrovascular disease within 6 months
  • EF (Ejection Fraction) < 45%
  • Non-cooperative or patients who do not agree to participate in the study

Treatment and study plan

Primary outcomes

  1. Preoperative systemic immune inflammatory index (SII)

    Time frame: within 3 days preoperatively

    It will be calculated as: platelet count x neutrophil count / lymphocyte count from routine complete blood count

  2. Postoperative systemic immune inflammatory index (SII)

    Time frame: in the first 24 hours postoperatively

    It will be calculated as: platelet count x neutrophil count / lymphocyte count from routine complete blood count

  3. Preoperative systemic inflammatory response index (SIRI)

    Time frame: within 3 days preoperatively

    It will be calculated as: neutrophil count x monocyte count/lymphocyte count from routine complete blood count

  4. Postoperative systemic inflammatory response index (SIRI)

    Time frame: in the first 24 hours postoperatively

    It will be calculated as: neutrophil count x monocyte count/lymphocyte count from routine complete blood count

  5. Preoperative neutrophile lymphocyte ratio (NLR)

    Time frame: within 3 days preoperatively

    It will be calculated as:neutrophil count/lymphocyte count from routine complete blood count

  6. Postoperative neutrophile lymphocyte ratio (NLR)

    Time frame: in the first 24 hours postoperatively

    It will be calculated as:neutrophil count/lymphocyte count from routine complete blood count

  7. Preoperative platelet lymphocyte ratio (PLR)

    Time frame: within 3 days preoperatively

    It will be calculated as: platelet count/lymphocyte count from routine complete blood count

  8. Postoperative platelet lymphocyte ratio (PLR)

    Time frame: in the first 24 hours postoperatively

    It will be calculated as: platelet count/lymphocyte count from routine complete blood count

  9. Preoperative c-reactive protein

    Time frame: within 3 days preoperatively

    from routine preoperative blood sample ( milligram/decilitre)

  10. Preoperative procalcitonin

    Time frame: within 3 days preoperatively

    from routine preoperative blood sample ( microgram/litre)

  11. Postoperative c-reactive protein

    Time frame: in the first 24 hours postoperatively

    from routine postoperative blood sample ( milligram/decilitre)

  12. Postoperative procalcitonin

    Time frame: in the first 24 hours postoperatively

    from routine postoperative blood sample ( microgram/litre)

  13. Postoperative complications

    Time frame: within the first 24 hours after surgery

    Postoperative complications consisting of:

    • newly developed atrial fibrillation
    • need for cardiac pacing
    • need for ECMO (Extracorporeal membrane oxygenation)
    • need for IABP (Intra-Aortic Balloon Pump)
    • prolonged mechanical ventilation
    • pericardial effusion
    • cardiac arrest
    • cerebrovascular event
    • delirium
    • exitus
    • other complications.

Secondary outcomes

  1. Patient comorbidities

    Time frame: preoperative within 48 hours

    Patient comorbidities will be assessed

  2. Transfusion requirement

    Time frame: during the operation

    Incidence of transfusion of blood and blood products to the patient

  3. Inotrope requirement

    Time frame: during the operation

    Incidence of inotrope usage, inotropes consisting of:

    • noradrenaline
    • dopamine
    • dobutamine

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Effect of Total Intravenous Anesthesia or Inhalation Anesthesia on Inflammatory Biomarkers in Coronary Artery Bypass Surgery and Their Relationship With Early Postoperative Complications a Prospective Observational Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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