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临床试验/NCT04520503
NCT04520503已完成不适用

Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年9月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)

研究概览

简要总结

The induction dose of propofol is generally determined based on patients' characteristics, underlying disease, general condition, and also by clinician's experiences. However, It is difficult to anticipate and objectively calculate an adequate dose of propofol for every patient considering the variability of an individual's response to propofol. If there is a specific pattern in EEG prior to induction of anesthesia that can provide information about the patient's susceptibility to propofol, every induction may be performed far more smoothly with a precisely optimized dose of propofol for each patient. The study is to find a relationship between the pre-induction EEG pattern of adult patients and their sensitivity to propofol.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients undergoing general anesthesia

排除标准

  • •Patients undergoing cardiac or brain surgery
  • •Patients with neurological deficit or impaired communication (Glasgow Coma Scale < 15)
  • •Unstable vital sign (cardiogenic, hemorrhagic, septic shock)
  • •Patients with eclampsia
  • •Patients who administered preoperative anxiolytics
  • •Patients who do not require intubation
  • •Patients who are considered unsuitable for the study

研究组 & 干预措施

Pre EEG group

This cohort includes all participants in this study. EEG sensor will be attached to the patient's forehead before induction of anesthesia. Patterns of EEG and data will be obtained

干预措施: EEG monitoring (Device)

Pre EEG group

This cohort includes all participants in this study. EEG sensor will be attached to the patient's forehead before induction of anesthesia. Patterns of EEG and data will be obtained

干预措施: Propofol (Drug)

结局指标

主要结局

Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)

时间窗: During the induction of anesthesia (up to 15 min)

Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)

Processed EEG index (PSI; patient state index)

时间窗: During the induction of anesthesia (up to 15 min)

Processed EEG index (PSI; patient state index)

Mean frequency and 95% spectral edge frequency (Hz)

时间窗: During the induction of anesthesia (up to 15 min)

Mean frequency and 95% spectral edge frequency (Hz)

Burst suppression ratio (%)

时间窗: During the induction of anesthesia (up to 15 min)

Burst suppression ratio (%)

次要结局

  • The effect-site concentrations of propofol at loss of consciousness (μg/ml)(During the induction of anesthesia (up to 15 min))
  • The dose of propofol required for loss of consciousness (mg)(During the induction of anesthesia (up to 15 min))
  • Total amount of propofol used (mg)(During the induction of anesthesia (up to 15 min))
  • Time to loss of consciousness (second)(During the induction of anesthesia (up to 15 min))
  • Vital sign - blood pressure(During the induction of anesthesia (up to 15 min))
  • Vital sign - heart rate(During the induction of anesthesia (up to 15 min))
  • Administration of vasopressors (ephedrine, phenylephrine, epinephrine, etc)(During the induction of anesthesia (up to 15 min))

研究者

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

Jin-Tae Kim

Professor (full)

Seoul National University Hospital

研究点 (1)

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