Transesophageal Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia on the Cardiac Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- systolic function by TEE (fractional area change and ejection fraction)
研究概览
简要总结
Dexmedetomidine is a selective alpha-2 adrenergic agonist that can be considered as an adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its cardiovascular effect through activation of receptors in central and peripheral nervous system. The classic cardiovascular response of dexmedetomidine is the biphasic with initial short-term increase in blood pressure followed by long-lasting decrease in BP and HR. There were several reports about these hemodynamic changes of dexmedetomidine, but not the evaluation of direct effects on cardiac function. The purpose of this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant on cardiac function by using the transesophageal echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 20 years of age.
- •American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- •general anesthesia
排除标准
- •severe functional liver or kidney disease
- •diagnosed HF ( NYHA class >3)
- •arrhythmia or received treatment with antiarrythmic drug .
- •severe bradycardia (HR < 45 bpm) and AV block
- •pathologic esophageal lesion (esophageal stricture or varix )
研究组 & 干预措施
Dexmedetomidine group
Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for 10 minutes; resulting in a loading dose of 1 mcg/kg, followed by an infusion of 0.5 μg/kg/hr for 50 minutes.
干预措施: Dexmedetomidine, Transesophageal echocardiography(TEE) (Drug)
Control group
Saline will be infused at a rate of 6 mcg/kg/hr for 10 minutes; resulting in a loading dose of 1 mcg/kg, followed by an infusion of 0.5 μg/kg/hr for 50 minutes.
干预措施: Saline will be infused for 60 minutes at the same rates as dexmedetomidine group. (Drug)
结局指标
主要结局
systolic function by TEE (fractional area change and ejection fraction)
时间窗: The participants will be followed for 1 hour after study drug is administered.
Systolic function measured transesophageal echocardiographically by fractional area change and ejection fraction.
次要结局
- diastolic function by TEE (ratio between early transmitral flow (E) and mitral annular tissue velocity (E')(The participants will be followed for 1 hour after study drug is administered.)