Effect of Dexmedetomidine on Stress-induced Changes in Hemodynamics and Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- post-operative ventricular function.
研究概览
简要总结
50 patients of both sexes undergoing elective CABG surgery will be randomly divided into 2 groups, study group (Dex) group and control group (C) to determine the effect of dexmedetomidine on the peri-operative hemodynamic changes during CABG surgery.
详细描述
The effect of dexmedetomidine during CABG surgery is studied regarding Ventricular function, pre bypass and post bypass using the transoeophageal echo (TEE), post-operative by transthoracic echocardiography (TTE) on day of surgery and after extubation.
Incidence of intraoperative and post operative ischemia and arrhythmias using Electrocardiogram (ECG) as well as the length of ICU and hospital stay.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing elective CABG surgery
排除标准
- •Patient refusal
- •Dementia patients
- •Poor ventricular function with ejection fraction below 40%
- •Asthmatic patients
- •Uncontrolled diabetic patients with HbA1c above 8
- •Combined surgeries (CABG+ valves)
- •Emergency surgeries.
- •Pre-existing arrhythmia
- •Patients with renal impairment
- •Patients with hepatic impairment
- •Patients with heart block
- •Off-pump CABG
研究组 & 干预措施
Dexmedetomidine group
patients will have loading Dexmedetomidine( 1ug/kg) over 10 minutes followed by continuous infusion of (0.5ug/kg/hr) from the initiation of anaesthesia up to extubation in the ICU. Patients will not be extubated until completely awake and have no sign of arrhythmias and bleeding
干预措施: Dexmedetomidine (Drug)
control group
patients will receive the same volume of 0.9% saline infusion as loading and maintenance infusion.
干预措施: normal saline (Other)
结局指标
主要结局
post-operative ventricular function.
时间窗: Up to 24 hours postoperative
global systolic function Ejection Fraction by TTE postoperative
Intra-operative ventricular function.
时间窗: Intraoperative
global systolic function Ejection Fraction by TEE intraoperative
次要结局
- hemodynamics(Immediate postoperative and up to 24 hours postoperative)
研究者
Rania Maher Hussien, MD
Associate professor of Anesthesia
Ain Shams University