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临床试验/NCT02199067
NCT02199067终止不适用

Measurement of Exhaled Propofol During a Total Intravenous Anesthesia With Propofol and Remifentanil

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
20
试验地点
1
主要终点
exhaled propofol levels in breathing gas

研究概览

简要总结

Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total intravenous anaesthesia with propofol is done only by experience of the anaesthetist or according to pharmacokinetic models. In this study we want to investigate if the exhaled fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled propofol will be measured with an electrochemical sensor developed by "Drägerwerk AG & Co. KGaA". Exhaled propofol levels will be compared with the corresponding arterial serum concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol levels with the Bispectral Index (BIS).

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA (American Society of Anaesthesiologists) classification I & II
  • Body-Mass-Index < 35
  • elective surgery with the necessity of an arterial catheter

排除标准

  • chronic obstructive lung disease
  • bronchial asthma
  • smokers with more than 5 packyears
  • peripheral artery occlusive disease
  • diabetes mellitus

结局指标

主要结局

exhaled propofol levels in breathing gas

时间窗: continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)

次要结局

  • Bispectral Index (BIS)(continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours))
  • propofol concentration in arterial blood serum(samples taken during anaesthesia (13 blood samples), duration of anaesthesia depends on surgery, 2 to 12 hours)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tino Münster

Prof. Dr.

University of Erlangen-Nürnberg Medical School

研究点 (1)

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