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临床试验/NCT01604226
NCT01604226Unknown不适用

Predicting Bispectral Index Values by Estimated Effect-site Concentration of Propofol and Remifentanil Displayed on the Target-centered Infusion Pump

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Bispectral index value

研究概览

简要总结

The BIS is influenced by multiple parameters, such as age,gender, body weight, height, muscle relaxants, hepatic function, co-administered drugs, surgical stimulation, but is thought to be influenced mainly by propofol and remifentanil infusion dose. As such, the investigators postulate that the BIS value could be predicted by the estimated effects-site concentration of propofol and remifentanil, and try to establish a multiple linear regression model for predicting BIS value.

详细描述

Total intravenous anesthesia is commonly performed with propofol and remifentanil now-a-days. The combination of these two drugs can achieve the rapid loss of consciousness and analgesia,as the onset and recovery time of these two drugs are very fast within one to three minutes. However, the problem of intraoperative awareness necessitate the monitoring of anesthetic depth, which is commonly performed with Bispectral index (BIS). BIS is a display of number from zero to one hundred which quantify the degree of sedation and hypnosis by anesthetics by analyzing the electroencephalogram. However, it is limited in neurosurgery in which the surgical field is near the forehead where the BIS probe is attached. Furthermore, it is also limited in surgery with prone position. The BIS is influenced by multiple parameters, such as age,gender, body weight, height, muscle relaxants, hepatic function, co-administered drugs, surgical stimulation, but is thought to be influenced mainly by propofol and remifentanil infusion dose. As such, we postulate that the BIS value could be predicted by the estimated effects-site concentration of propofol and remifentanil, and try to establish a multiple linear regression model for predicting BIS value.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those undergoing gynecologic or urologic surgery with general anesthesia with total intravenous anesthesia
  • Adult patients with more than 20 yrs.
  • American Society of Anesthesiologists Class I or II.

排除标准

  • Those with unstable hemodynamics
  • Those who can not undergo Bispectral index monitoring
  • Those with previous history of stroke

结局指标

主要结局

Bispectral index value

时间窗: every 10 min after anesthetic induction

Bispectral index value after anesthetic induction every 10 minutes interval until the end of surgery

次要结局

  • Propofol concentration(every 10 min after anesthetic inducton)
  • Remifentanil concentration(every 10 minutes after anesthetic induction)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sangmin M. Lee

Professor

Samsung Medical Center

研究点 (1)

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