Skip to main content
Clinical Trials/NCT06209437
NCT06209437
Completed
Not Applicable

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

Ankara City Hospital Bilkent1 site in 1 country228 target enrollmentJanuary 8, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Ankara City Hospital Bilkent
Enrollment
228
Locations
1
Primary Endpoint
Preoperative neutrophile lymphocyte ratio (NLR)
Status
Completed
Last Updated
last year

Overview

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?

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2024
End Date
June 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

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

Postoperative procalcitonin

Time Frame: in the first 24 hours postoperatively

from routine postoperative blood sample ( microgram/litre)

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

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

Preoperative c-reactive protein

Time Frame: within 3 days preoperatively

from routine preoperative blood sample ( milligram/decilitre)

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.

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

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

Preoperative procalcitonin

Time Frame: within 3 days preoperatively

from routine preoperative blood sample ( microgram/litre)

Postoperative c-reactive protein

Time Frame: in the first 24 hours postoperatively

from routine postoperative blood sample ( milligram/decilitre)

Secondary Outcomes

  • Inotrope requirement(during the operation)
  • Patient comorbidities(preoperative within 48 hours)
  • Transfusion requirement(during the operation)

Study Sites (1)

Loading locations...

Similar Trials