Anesthesia Management of Coronary Artery Bypass Surgery and Inflammatory Biomarkers

NCT06209437 | Completed

• 1 other identifier: volgaozkan1
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Coronary Artery Disease; Postoperative Complications; Anesthesia

Outcome Measures

Primary Outcomes (13)

• Preoperative systemic immune inflammatory index (SII)

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

  within 3 days preoperatively

• Postoperative systemic immune inflammatory index (SII)

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

  in the first 24 hours postoperatively

• Preoperative systemic inflammatory response index (SIRI)

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

  within 3 days preoperatively

• Postoperative systemic inflammatory response index (SIRI)

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

  in the first 24 hours postoperatively

• Preoperative neutrophile lymphocyte ratio (NLR)

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

  within 3 days preoperatively

• Postoperative neutrophile lymphocyte ratio (NLR)

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

  in the first 24 hours postoperatively

• Preoperative platelet lymphocyte ratio (PLR)

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

  within 3 days preoperatively

• Postoperative platelet lymphocyte ratio (PLR)

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

  in the first 24 hours postoperatively

• Preoperative c-reactive protein

  from routine preoperative blood sample ( milligram/decilitre)

  within 3 days preoperatively

• Preoperative procalcitonin

  from routine preoperative blood sample ( microgram/litre)

  within 3 days preoperatively

• Postoperative c-reactive protein

  from routine postoperative blood sample ( milligram/decilitre)

  in the first 24 hours postoperatively

• Postoperative procalcitonin

  from routine postoperative blood sample ( microgram/litre)

  in the first 24 hours postoperatively

• Postoperative complications

  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.

  within the first 24 hours after surgery

Secondary Outcomes (3)

• Patient comorbidities

  preoperative within 48 hours

• Transfusion requirement

  during the operation

• Inotrope requirement

  during the operation

Study Arms (2)

Inhalation Anesthesia Group

After induction, anesthesia will be provided with sevoflurane (2.0 mac) and intravenous remifentanil infusion (0.05-0.2 mcg/kg/min). Depth of anesthesia will be evaluated with Bispectral Index (BIS).

Total Intravenous Anesthesia Group

After induction, anesthesia will be provided with intravenous propofol infusion (50-150 mcg/kg/min) and intravenous remifentanil infusion (0.05-0.2 mcg/kg/min). Depth of anesthesia will be evaluated with Bispectral Index (BIS).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ASA (American Society of Anesthesiologists) II- III patients over the age of 18 who will undergo on-pump bypass surgery in Ankara City Hospital Bilkent and who agree to participate in the study

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara city hospital bilkent

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease; Postoperative Complications

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: January 8, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

TU (1)