IMPACT OF CARDIAC AUTONOMIC NEUROPATHY ON QT AND QTC INTERVAL IN PATIENTS SCHEDULED FOR CORONARY ARTERY BYPASS GRAFTING
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Perioperative change in corrected QT (QTc) interval
研究概览
简要总结
This prospective observational cohort study evaluated the effect of cardiac autonomic neuropathy (CAN) on perioperative ventricular repolarization, specifically QT and corrected QT (QTc) intervals, in patients undergoing elective coronary artery bypass grafting (CABG) surgery under general anesthesia. The study was conducted in a tertiary care university hospital between October 2023 and December 2024.
Adult patients scheduled for isolated elective CABG surgery with sinus rhythm on preoperative electrocardiography were screened for eligibility. Cardiac autonomic function was assessed preoperatively using standardized Ewing's cardiovascular reflex tests. Patients were classified into two groups according to test results: CAN-positive (≥2 abnormal tests) and CAN-negative (<2 abnormal tests).
QT and QTc intervals were measured at predefined perioperative time points, including before anesthesia induction, baseline, before intubation, at 1 and 30 minutes after intubation, before cannulation, and 24 hours postoperatively. The primary objective was to compare perioperative QT and QTc interval changes between patients with and without CAN. Secondary outcomes included QT and QTc variability (ΔQT, ΔQTc) and the incidence of clinically significant QTc prolongation.
详细描述
This prospective observational study was designed to evaluate the impact of cardiac autonomic neuropathy (CAN) on perioperative ventricular repolarization parameters, specifically QT and corrected QT (QTc) intervals, in patients undergoing elective coronary artery bypass grafting (CABG) surgery under general anesthesia. The study was conducted at a tertiary care university hospital within the Departments of Anesthesiology and Cardiovascular Surgery between October 2023 and December 2024.
Patients scheduled for elective isolated CABG surgery with sinus rhythm on preoperative electrocardiography were screened for eligibility. Cardiac autonomic function was assessed preoperatively using standardized Ewing's cardiovascular reflex tests. Based on test results, patients were classified into two groups: CAN-positive (≥2 abnormal tests) and CAN-negative (<2 abnormal tests).
QT and QTc intervals were measured at predefined perioperative time points, and variability of repolarization parameters was also assessed. The primary aim was to compare perioperative QT and QTc interval changes between patients with and without CAN.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Scheduled for elective isolated coronary artery bypass grafting (CABG).
- •Sinus rhythm on preoperative 12-lead electrocardiography.
- •Ability to undergo preoperative cardiovascular autonomic function assessment using Ewing's cardiovascular reflex tests.
- •Written informed consent provided.
排除标准
- •Previous cardiac surgery.
- •Emergency CABG.
- •Permanent pacemaker implantation.
- •Atrial fibrillation or other clinically significant cardiac arrhythmias.
- •Bundle branch block.
- •Congenital long QT syndrome.
结局指标
主要结局
Perioperative change in corrected QT (QTc) interval
时间窗: Before anesthesia induction (baseline), immediately before tracheal intubation, 1 minute after intubation, 30 minutes after intubation, before cardiopulmonary bypass cannulation, and 24 hours after surgery.
Corrected QT (QTc) interval measured from lead II electrocardiography using Bazett's formula and compared between patients with and without cardiac autonomic neuropathy at predefined perioperative time points.
次要结局
- QT interval variability (ΔQT)(From anesthesia induction to 24 hours after surgery.)
- Corrected QT interval variability (ΔQTc)(From anesthesia induction to 24 hours after surgery.)
- Incidence of QTc prolongation(From anesthesia induction to 24 hours after surgery.)
- Incidence of clinically significant QTc change(From anesthesia induction to 24 hours after surgery.)
研究者
Sinan Uzman
Assoc prof.
Haseki Training and Research Hospital