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临床试验/NCT01477905
NCT01477905已完成不适用

Study of Proper Operation of the Syringe Pump Used in Priming of the Syringe

Ajou University School of Medicine2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
delivered infusates of remifentanil

研究概览

简要总结

The investigators attempted to determine an adequate priming volume for our infusion system, and investigated the extent of a possible delay of the drug effect, that would result from mechanical defects of the infusion system, with or without priming the infusion system, using direct gravimetrical measurements of virtual infusate amounts during target controlled infusion of 2 remifentanil diluents.

详细描述

Priming the infusion system (PRIMING) was performed using an evacuation of 2.0 ml to the atmosphere prior to Target-controlled Infusion (TCI). Forty eight TCI, using 50 μg/ml or 20 μg/ml of remifentanil diluents, were performed targeting 4.0 ng/ml of effect site concentration (Ceff), with or without PRIMING. Using simulations, the gravimetrical measurements of the delivered infusates reproduced actual predicted concentrations.

研究设计

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

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • electric medical records of the patients who had undergone general anaesthesia

排除标准

  • body weight exceeding 20% of ideal body weight

结局指标

主要结局

delivered infusates of remifentanil

时间窗: base line from 30 min of TCI was maintained

For targetting an effect-site concentration (Ceff) of 4.0 ng/ml, were randomly performed using 50 μg/ml (Remi50) or 20 μg/ml (Remi20) of remifentanil, and with or without PRIMING, TCI data files, including predicted plasma (Cp-proper), and effect-site (Ceff-proper) concentrations were saved

次要结局

未报告次要终点

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Yeop Kim

Associate professor

Ajou University School of Medicine

研究点 (2)

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