Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia in Off-pump Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- left ventricular ejection fraction
研究概览
简要总结
the study will assess the impact of intraoperative dexmedetomidine infusion on myocardial performance by investigating the left ventricular (LV) systolic and diastolic function and right ventricular (RV) fraction area change (which reflect RV systolic function) using two-dimensional trans-esophageal echocardiography (TEE) in patients undergoing elective first-time isolated off-pump coronary artery bypass (OPCAB) grafting. LV Systolic function will be measured by the TEE via the fractional area change, fraction shortening, and ejection fraction.
详细描述
Off pump coronary revascularization is an old technique performed first in St Petersburg in 1964, Off pump coronary artery surgery has been developed following two different approaches. Minimally invasive direct-access coronary artery bypass (MIDCAB) that consists of anastomosing the left internal mammary artery to the left anterior descending coronary artery through small anterior left thoracotomy, The second approach is multi-vessel grafting without CPB performed through standard median sternotomy. Dexmedetomidine (Dex), a highly selective α2-adrenergic receptor agonist, is widely used for sedation and analgesia in the ICU or as an anesthetic adjuvant.
This study will be a prospective comparative controlled randomized double blinded clinical trial on 36 patients divided into control ,and dexmedetomidine group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective first-time off-pump isolated coronary artery bypass graft (OPCAB) surgery
- •Patients with good ventricular functions.
- •Patients with normal levels of cardiac troponin I and myocardial enzymes
- •Patients of Body Mass Index (BMI) more than 20 and less than 34.
排除标准
- •Severe functional liver or kidney disease.
- •Diagnosed HF (NYHA class >3).
- •Arrhythmia or received treatment with anti-arrhythmic drugs.
- •Severe bradycardia (HR < 45 bpm) and AV block.
- •Pathologic esophageal lesion (esophageal stricture or varix )
- •Pregnancy.
研究组 & 干预措施
dex group
patients medicated with dexmedetomidine.
干预措施: Dexmedetomidine (Drug)
control group
patients took placebo normal saline.
干预措施: normal saline (Drug)
结局指标
主要结局
left ventricular ejection fraction
时间窗: immediatly after sternal closure
using transesophageal echocardiography, ejection fraction will be assessed by the ratio of stroke volume and end diastolic volume
left ventricular fractional shorting
时间窗: immediatly after sternal closure
using transesophageal echocardiography, fractional area change of the left ventricle will be calculated
left ventricular diastolic function
时间窗: immediatly after sternal closure
using transesophageal echocardiography, diastolic function (filling ratio) will be assessed by the ratio between early transmitral flow (E) and mitral annular tissue velocity (E').
次要结局
- right ventricular systolic function(immediatly after sternal closure)
研究者
Abdelrhman Alshawadfy
Lecturer of anesthesia and intensive care
Suez Canal University