High Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index and Coronary Vascular Disease During Aortic Valve Replacement Alone or in Addition to Coronary Artery Bypass Graft Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The changes in LV systolic.
研究概览
简要总结
Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF). This study Aim to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV function in patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG). It Designs as A prospective randomized controlled comparative study in which eighty patients received either general anesthesia ( control group n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition to (CABG).
详细描述
Background: Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF).
Aim: to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV function in patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG).
Design: A prospective randomized controlled comparative study. Methods: Eighty patients received either general anesthesia ( control group n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition to (CABG).Perioperative heart rate (HR), mean arterial blood pressure (MAP), incidence of ischemic ECG, LV systolic and diastolic function changes were measured till 48 h, postoperatively.
Patients were subjected to ambulatory Holter monitoring, Hemodynamic measures, intraoperative transesophageal echocardiography (iTEE) and postoperative Trans Thoracic Echocardiography (TTE) to assess myocardial ischemia and Left ventricular systolic/diastolic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients between 65 and 75 years with:
- •physical status of ASA II and IV
- •who underwent aortic valve replacement (for isolated or mixed aortic valve lesions) alone or in addition to-coronary artery bypass grafting. in the Cardio-thoracic Surgery Department of Tanta University Hospital during a two year period were enrolled in this study.
- •Before inclusion in the study, all patients were evaluated with extended echocardiographic imaging, full history including cardiac symptoms (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, chest pain, and low cardiac output symptoms) was taken from all patients. General (including body weight and height) and systematic (including cardiac examination) examinations were done to all patients.
排除标准
- •Patients with an ejection fraction of 0.3, myocardial infarction within the last 4 weeks
- •severe pulmonary or arterial hypertension.
- •a contraindication for HTEA.
- •patients without preoperative optimal echocardiographic imaging were excluded.
- •Among the exclusion criteria were the administration of ticlopidine within 15 days before surgery and the administration of platelet glycoprotein IIb/IIIa inhibitors. In common with previous investigators, we did not consider treatment with low-molecular-weight heparin and aspirin below the dosage of 160 mg/day to be contraindications to the procedure.
- •Patients with significant aortic insufficiency were also excluded from the study in order to avoid introducing further variables that could influence hemodynamic response to the procedure.
- •Patients were excluded if they underwent an AVR on an emergency basis, had poor acoustic windows for adequate echocardiographic assessment, and/or did not undergo an echocardiogram before the operation.
研究组 & 干预措施
HTEA Group + N(LVMI)+ AVR alone(n=10)
HTEA Group + N(LVMI)+ AVR alone(n=10)
干预措施: thoracic epidural (Device)
HTEA Group + ↑ (LVMI)+ AVR alone(n=10)
HTEA Group + ↑ (LVMI)+ AVR alone(n=10)
干预措施: thoracic epidural (Device)
HTEA Group + N(LVMI)+ AVR + CABG(n=10)
HTEA Group + N(LVMI)+ AVR + CABG(n=10)
干预措施: thoracic epidural (Device)
HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)
HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)
干预措施: thoracic epidural (Device)
Control(GA) Group+ N(LVMI)+ AVR alone(n=10)
Control(GA) Group+ N(LVMI)+ AVR alone(n=10)
Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
Control(GA) Group+ N(LVMI)+ AVR + CABG(n=10)
(GA) Group+ N(LVMI)+ AVR + CABG(n=10)
Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)
Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)
结局指标
主要结局
The changes in LV systolic.
时间窗: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
LV end systolic diameter (LVESD)
The changes in LV diastolic.
时间窗: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
Left ventricular end diastolic diameter (LVEDD)
ejection fraction percent
时间窗: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
changes in percentage, of how much blood the left ventricle pumps out with each contraction.
FAC percent
时间窗: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
Fractional Area Change (FAC) percent Fractional Area Change (FAC)
EDA
时间窗: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
end-diastolic area (EDA)
次要结局
- the changes incidence of ischemic ECG.(5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively)
- Perioperative changes in heart rate (HR).(5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively)
- changes in mean arterial blood pressure (MAP)(5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively)
研究者
Ahmed Said Elgebaly,MD
director
Tanta University