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临床试验/NCT01584570
NCT01584570已完成不适用

The Effects of Dexmedetomidine and Tracheal Intubation on Heart Rate Variability and QTc Interval

Yonsei University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年1月1日最近更新:
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
80
试验地点
1
主要终点
Change of QTc interval

研究概览

简要总结

The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation on heart rate variability and QTc interval.

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
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patient who are regarded as ASA class I
  • age 20 to 60
  • patient scheduled for Intubation for surgery

排除标准

  • QTc interval > 440 ms
  • arrythmia
  • Patient who is taking a medicine which effects QTc interval
  • renal disease
  • hepatic disease
  • illiterate

研究组 & 干预措施

Control

Active Comparator

fentanyl 1 mcg/kg before induction

干预措施: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min (Drug)

D 0.5 group

Experimental

Dexmedetomidine 0.5 ug/kg + Propofol + Sevoflurane+ Vecuronium

干预措施: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min (Drug)

D 1.0 group

Experimental

Dexmedetomidine 1.0 ug/kg + Propofol + Sevoflurane+ Vecuronium

干预措施: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min (Drug)

结局指标

主要结局

Change of QTc interval

时间窗: T1 (at rest), T2 (5 min after dexmedetomidine infusion), T3 (just before intubation), T4(1 min after intubation), T5(2 min after intubation), T6(3min after intubation)

T1- baseline, T2- to evaluate the effect of dexmedetomidine on QTc interval, T3- to evaluate QTc interval just before intubation, T4,5,6 - to evaluate QTc interval after intubation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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