Anesthesia Management of Coronary Artery Bypass Surgery and Inflammatory Biomarkers

Coronary Artery Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209437
• Other study ID #: volgaozkan1
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: June 28, 2024

Study information

• Verified date: January 2024
• Source: Ankara City Hospital Bilkent
• Contact: Efe Volga Özkan, MD
• Phone: 5073604840
• Email: volgaozkan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 28, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Coronary Artery Disease
• Postoperative Complications

Locations

Country	Name	City	State
Turkey	Ankara city hospital bilkent	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Preoperative neutrophile lymphocyte ratio (NLR)	It will be calculated as:neutrophil count/lymphocyte count from routine complete blood count	within 3 days preoperatively
Primary	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
Primary	Preoperative platelet lymphocyte ratio (PLR)	It will be calculated as: platelet count/lymphocyte count from routine complete blood count	within 3 days preoperatively
Primary	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
Primary	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	Patient comorbidities	Patient comorbidities will be assessed	preoperative within 48 hours
Secondary	Transfusion requirement	Incidence of transfusion of blood and blood products to the patient	during the operation
Secondary	Inotrope requirement	Incidence of inotrope usage, inotropes consisting of: noradrenaline; dopamine; dobutamine	during the operation