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临床试验/NCT02777619
NCT02777619已完成4 期

Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Target-controlled Infusion Intravenous Anesthesia During the Induction

Guangzhou General Hospital of Guangzhou Military Command1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
The EC50 of propofol for loss of consciousness

研究概览

简要总结

The purpose of this study is to determine pharmacodynamic interactions of propofol and dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median effective concentration (EC50).

详细描述

64 cases were randomly divided into four groups, In each group, dexmedetomidine target plasma concentration are 0, 0.4, 0.6, 0.8 ng/ml. Dexmedetomidine administered 15 min before target controlled infusion of propofol. The propofol infusion was started to provide a target effect-site concentration of 1.0ug/ml, and increased by 0.2ug/ml until loss of consciousness when the effect-site concentration and target concentration equilibrium.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Weight:18≦ BMI≦25
  • Written informed consent from the patient or the relatives of the participating patient.

排除标准

  • A previous history of intolerance to the study drug or related compounds and additives.
  • Existing significant haematological, endocrine, metabolic or gastrointestinal disease.

研究组 & 干预措施

Propofol and 0.0ng/ml Dexmedetomidine

Placebo Comparator

Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.0ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears.

干预措施: 0.0ng/ml Dexmedetomidine (Drug)

Propofol and 0.0ng/ml Dexmedetomidine

Placebo Comparator

Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.0ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears.

干预措施: Propofol (Drug)

Propofol and 0.4ng/ml Dexmedetomidine

Experimental

Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.4ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears.

干预措施: 0.4ng/ml Dexmedetomidine (Drug)

Propofol and 0.4ng/ml Dexmedetomidine

Experimental

Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.4ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears.

干预措施: Propofol (Drug)

Propofol and 0.6ng/ml Dexmedetomidine

Experimental

Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.6ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears.

干预措施: 0.6ng/ml Dexmedetomidine (Drug)

Propofol and 0.6ng/ml Dexmedetomidine

Experimental

Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.6ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears.

干预措施: Propofol (Drug)

Propofol and 0.8ng/ml Dexmedetomidine

Experimental

Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.8ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears.

干预措施: 0.8ng/ml Dexmedetomidine (Drug)

Propofol and 0.8ng/ml Dexmedetomidine

Experimental

Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.8ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears.

干预措施: Propofol (Drug)

结局指标

主要结局

The EC50 of propofol for loss of consciousness

时间窗: within 30 min during the induction of anesthesia

The aim of the investigators study is to define the optimum target concentration (EC50) of propofol for loss of consciousness with different dexmedetomidine target plasm concentration.

次要结局

  • The EC95 of propofol for loss of consciousness(within 30 min during the induction of anesthesia)

研究者

发起方
Guangzhou General Hospital of Guangzhou Military Command
申办方类型
Other
责任方
Principal Investigator
主要研究者

bo xu

Associate Professor

Guangzhou General Hospital of Guangzhou Military Command

研究点 (1)

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