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临床试验/NCT03807271
NCT03807271已完成不适用

Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model

Norwegian University of Science and Technology2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2019年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
2
主要终点
Mean Arterial Pressure (MAP)

研究概览

简要总结

There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and postoperative complications in the patient undergoing surgery. Having a unnecessary "deep" anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause delirium and increase the mortality rate. Being too "light", on the other hand, can make the patient experience awareness when muscle relaxant is used. This can lead to serious psychological struggles.

Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can be difficult because clinical signs depend on many factors. In addition to clinical evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice. Unfortunately, this method is not always accurate and has a delay.

New devices are now developed to calculate the anesthesia level based on the drugs given. The level is simultaneously presented graphically on screen. The purpose of this study is to investigate and compare clinical parameters within patients undergoing general anesthesia, with and without the use of such devices. Hemodynamic stability, less use of adrenergics, higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate a more precise level of anesthesia, hence, promote patient safety.

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
Single (Participant)

盲法说明

The anesthesia team must know if the anesthesia will be given by standard procedure or guided by the calculating device in addition.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Standard premedication
  • General anesthesia, total intravenous anesthesia

排除标准

  • Alcoholics
  • BMI 35 or higher
  • Unable to give consent

结局指标

主要结局

Mean Arterial Pressure (MAP)

时间窗: Maximum 5 hours

次要结局

  • Total dosis of Ephedrine in milligrams(Maximum 5 hours)
  • Duration of surgery in minutes(Maximum 5 hours)
  • Total dosis of Norepinephrine in micrograms(Maximum 5 hours)
  • Bispectral Index (BIS)(Maximum 5 hours)
  • Total dosis of Propofol in milligrams(Maximum 5 hours)
  • Heart Rate (HR)(Maximum 5 hours)
  • Total dosis of Phenylephrine in micrograms(Maximum 5 hours)
  • Total dosis of Remifentanil in micrograms(Maximum 5 hours)
  • Total dosis of Atropine in micrograms(Maximum 5 hours)
  • Time until extubation in minutes(Maximum 5 hours)
  • Duration of anesthesia in minutes(Maximum 5 hours)
  • Duration of stay in postoperative ward in minutes(Maximum 2 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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