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临床试验/NCT02155010
NCT02155010已完成不适用

Hemodynamic Effect of Dexmedetomidine on Heavy Bupivacaine Spinal Anesthesia

Inje University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2014年3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
74
试验地点
1
主要终点
Incidence of Hypotension

研究概览

简要总结

Patients were randomized into two groups, A group and B group. A group and B group patients are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine, respectively.

The investigators will compare of hemodynamics and patient's comfortability between two groups.

详细描述

A and B group patients will intravenous inject dexmedetomidine 1mcg/kg for 10 minute loading infusion and 0.2mcg/kg/hr for continuous infusion. A group receive intravenous dexmedetomidine after procedure, and B group receive intravenous dexmedetomidine before procedure. Both group patients will hydrate 6 ml/kg crystalloid solution and will evaluated patient's anxiety and comfortability perioperative period. Vital signs will record 5 minutes interval at operating room and post-anesthetic care units.

研究设计

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

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

  • 20 - 60 aged patients
  • orthopedic operation undergoing spinal anesthesia

排除标准

  • more than American society of anesthesiologists classification 3
  • hypertension
  • diabetes mellitus
  • heart disease (bradycardia, atrioventricular block)

研究组 & 干预措施

Dexmedetomidine

Experimental

IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine with heavy bupivacaine

Active Comparator

IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine

干预措施: Dexmedetomidine with heavy bupivacaine (Drug)

结局指标

主要结局

Incidence of Hypotension

时间窗: up to 3 hours

We compare incidence rate of hypotension during infusion of dexmedetomidine

次要结局

  • Patient's Anxiety(up to 3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ki Hwa Lee

Assistant professor

Inje University

研究点 (1)

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