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临床试验/NCT01128465
NCT01128465已完成不适用

Investigation on the Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
prediction error for propofol plasma concentrations

研究概览

简要总结

Certain kind of neurosurgical procedures require intraoperative alertness of the patient, for example to perform speech tests during brain tumor resection. With respect to anaesthesia, it is therefore required that the patient is asleep during the beginning and the end of the procedure, however fully awake in between. To do so, the anaesthetic propofol is used and an accurate knowledge of its pharmacokinetic and -dynamic (pk/pd) parameters is required to optimally control anaesthesia. However, diverse pk/pd-parameter sets have been described in the literature.

The aim of the study is to investigate whether the pk/pd model proposed by Marsh et al. or by Schnider et al. more accurately describe the pk/pd of propofol during awake craniotomy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • patients scheduled for awake craniotomy

排除标准

  • pregnancy

结局指标

主要结局

prediction error for propofol plasma concentrations

时间窗: day of surgery (day 1)

On the day of surgery, plasma samples will be drawn during induction, maintenance and recovery from anesthesia. Subsequently the actually measured propofol plasma concentration will be compared with the predicted propofol plasma concentration (according to Marsh et al. and Schnider et al.), and the prediction error will be calculated.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bonn
申办方类型
Other

研究点 (1)

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