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临床试验/NCT01549639
NCT01549639已完成不适用

Use of a Novel Point of Care Device to Measure Blood Propofol Levels During Propofol Based General Anesthesia by Target Controlled Infusion Using the Marsh Model in Effect Site Mode

University Hospital Birmingham NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年1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
50
试验地点
1
主要终点
Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias)

研究概览

简要总结

Propofol is a commonly used agent for sedation and anaesthesia in the intensive care unit and the operating room. The pharmacokinetics of propofol are difficult to predict in patients not conforming to the norms in which the original pharmacokinetic research was based. Such patients, including the critically ill, and morbidly obese, are increasingly being encountered. The investigators group have been involved in the development of a device which can measure blood propofol concentrations, and hope for this to be available to use in the operating room in a clinically useful timeframe in the future. Data will be collected on patients undergoing propofol based general anaesthesia. The Marsh target controlled algorithm in effect site mode (commonly used by anaesthetists) will be assessed for accuracy using the propofol monitor. A new proportional correction method will be developed using this data, designed to enable recalibration of the TCI algorithm in near real time in order to achieve a more accurate estimated propofol concentration in these identified patient groups. The research will investigate the effectiveness of a correction of estimated propofol levels based on a one off measurement early on in the anaesthetic, and will take subsequent samples to measure propofol levels without modifying the TCI algorithm. Additionally, data on anaesthetist choice of TCI model, and method of administration in this relatively unselected group of patients will be analysed.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Only patients undergoing major surgery where blood sampling through arterial or central venous catheters is part of their routine clinical care will be recruited.
  • Only patients undergoing total intravenous anaesthesia using propofol will be recruited.

排除标准

  • Anaemic patients will not be recruited into the study.
  • Patients unable to consent will not be recruited into the study.

结局指标

主要结局

Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias)

时间窗: duration of anaesthesia (up to 24 hours)

次要结局

  • Median absolute percentage prediction error of estimated propofol concentration compared to measured concentrations (inaccuracy)(duration of anaesthesia (up to 24 hours))
  • Change in median percentage prediction error(bias)for propofol levels measured beyond thirty minutes following proportional correction at thirty minutes(thirty minutes)

研究者

发起方
University Hospital Birmingham NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas J Cowley

Lead investigator

University Hospital Birmingham NHS Foundation Trust

研究点 (1)

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