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临床试验/NCT06209437
NCT06209437已完成不适用

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 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2024年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
228
试验地点
1
主要终点
Preoperative neutrophile lymphocyte ratio (NLR)

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Preoperative neutrophile lymphocyte ratio (NLR)

时间窗: within 3 days preoperatively

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

Preoperative systemic immune inflammatory index (SII)

时间窗: 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)

时间窗: within 3 days preoperatively

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

Preoperative systemic inflammatory response index (SIRI)

时间窗: within 3 days preoperatively

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

Postoperative procalcitonin

时间窗: in the first 24 hours postoperatively

from routine postoperative blood sample ( microgram/litre)

Postoperative platelet lymphocyte ratio (PLR)

时间窗: 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)

时间窗: 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

时间窗: within 3 days preoperatively

from routine preoperative blood sample ( milligram/decilitre)

Postoperative complications

时间窗: 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)

时间窗: 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)

时间窗: in the first 24 hours postoperatively

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

Preoperative procalcitonin

时间窗: within 3 days preoperatively

from routine preoperative blood sample ( microgram/litre)

Postoperative c-reactive protein

时间窗: in the first 24 hours postoperatively

from routine postoperative blood sample ( milligram/decilitre)

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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