跳至主要内容
临床试验/NCT02490072
NCT02490072已完成不适用

Echocardiographic Evaluation of the Effects of Dexmedetomidine in Diastolic Dysfunction

Yonsei University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
biventricular diastolic function

研究概览

简要总结

Dexmedetomidine is a selective α2 adrenergic agonist that can be considered a primary anesthetic, 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 shorten-increase in blood pressure followed by long-lasting decrease in BP and HR. There were several reports about these hemodynamic changs of dexmedetomidine, but not the evaluation of direct cardiac function of patients who was preexisted diastolic dysfunction. The purpose of this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant in diastolic dysfunction by using the echocardiography.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria included patients who estimated lateral e' velocity <10 cm/s or septal e' velocity <8 cm/s from the mitral annuli and averaged E/e' ≧ 9 in preoperative echocardiographic evaluation. For patients of old age (> 60 yr) who did not undergo preoperative echocardiographic evaluation, written consent was obtained and TTE was performed to evaluate presence of diastolic dysfunction; patients with diastolic dysfunction, as previous defined, were included and those without were excluded
  • Above 40 years of age.
  • American Society of Anesthesiologists (ASA) Physical Status II, III.
  • Preserved systolic function (Ejection fraction > 50%)

排除标准

  • The exclusion criteria included patients who estimated lateral e' velocity >10 cm/s or septal e' velocity >8 cm/s from the mitral annuli, and averaged E/e' ≦ 8 in preoperative echocardiographic evaluation.
  • severe functional liver or kidney disease
  • diagnosed HF (LV ejection fraction <50% , or wall motion abnormality)
  • arrhythmia or received treatment with antiarrythmic drug .
  • severe bradycardia(HR < 45 bpm) and AV block
  • pathologic esophageal lesion (esophageal stricture or varix )
  • severe chronic obstructive lung disease.

研究组 & 干预措施

Dexmedetomidine group

Experimental

干预措施: Dexmedetomidine (Drug)

normal saline

Placebo Comparator

干预措施: normal saline(Saline 0.9%) (Drug)

结局指标

主要结局

biventricular diastolic function

时间窗: Change from baseline 10 min after induction (T1), 20 min after Dex loading (T2), 40 min after Dex loading (T3), 60 min after Dex loading(T4)

E/e'estimated by using tissue Doppler index

次要结局

  • Tei-index (myocardial performance index)(Change from baseline 10 min after induction(T1), 20 min after Dex loading (T2), 40 min after Dex loading (T3), 60 min after Dex loading(T4))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验