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临床试验/NCT02114437
NCT02114437Unknown4 期

Closed-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Index in Laparoscopic Cholecystectomy

Guangzhou General Hospital of Guangzhou Military Command1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
38
试验地点
1
主要终点
Narcotrend index

研究概览

简要总结

Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it difficult to judge the depth of anesthesia according to traditional hemodynamics index such as heart rate and blood pressure.In case of this, the investigators design this research to study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided by a Narcotrend index monitor in Laparoscopic Cholecystectomy.

详细描述

Anesthetics alter electrocortical activity in a dose-dependent manner,and it is suggested that electroencephalographic(EEG)activity can provide a reliable basis for a surrogate measurement of hypnosis.An EEG monitor,the Narcotrend Index(NI),has proven useful to titrate hypnotic drugs.Because it is a single composite measure monitored continuously,it has been used in controlled studies to automatically guide propofol administration.Conversely,automated delivery systems for opioids have seldom been described using EEG activity There are no specific measures to quantify analgesia directly.Nevertheless,in the interaction between opioid-hypnotic synergy and loss of consciousness,when the dose of analgesic administered is sufficient to inhibit autonomic response to noxious stimuli,then the required hypnotic concentration is only that needed to achieve loss of consciousness.Moreover,a noxious stimulus such as laryngoscopy or periosteal pressure to the tibia may cause electrocortical activation with an increase in Narcotrend index,which indirectly reflects the analgesic state or the level of antinociception.Finally,an excitatory EEG arousal reaction resulting from nociceptive stimulation can provide a rational basis for analgesia administration.It can then be hypothesized that Narcotrend index could also be the controlled variable for opioid administration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • require general anesthesia
  • expected to last>30 minutes
  • 18~90 years
  • ASA Ⅰ~Ⅳ level

排除标准

  • psychiatric illness
  • supraspinal neurological disorders
  • cranial neurosurgical procedures
  • patients equipped with a pacemaker

结局指标

主要结局

Narcotrend index

时间窗: 5minutes

the controller in the current study measures and calculates the error(NI error),which is the difference between the set point(NI=36)and the measured NI.If the NI error is different from 0,the controller determines a new propoflo and/or remifentanil concentration.The error size determines which drug will be modified:if the NI error is small,only the remifentanil is changed;if the NI error is higher,the two drug concentrations are changed.

次要结局

  • induction duration(within 10 minutes from the start of of propofol administration)

研究者

发起方
Guangzhou General Hospital of Guangzhou Military Command
申办方类型
Other
责任方
Principal Investigator
主要研究者

bo xu

associate chief physician

Guangzhou General Hospital of Guangzhou Military Command

研究点 (1)

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