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临床试验/NCT03876379
NCT03876379已完成不适用

Brain Power Spectral Density Under Propofol and Its Association With Cerebral Fragility, an Objective Means to Estimate the Probability of Presenting Burst Suppression

Joaquim MATEO0 个研究点目标入组 60 人开始时间: 2015年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Propofol doses administered with Target Controlled Infusion (TCI in µg/ml)

研究概览

简要总结

In the operating room, the state of anesthesia is monitored during general anesthesia-induced hypnosis through EEG-based neuro-monitoring. Recent studies suggest that variables extracted from per-operative EEG change as brain ages. Furthermore, aging is itself an independant factor associated to an increased sensitivity to General Anesthesia (GA). Among fragility sign, per-operative Burst Suppression (BS) has been associated to a poor postoperative cognitive trajectory. The main goal of this observational clinical study is to extend the traditional use of per-operative EEG to the detection and prediction of various degrees of brain fragility, depending on the depth of anesthesia (DoA).

详细描述

Main objective : Extend the traditional use of per-operative EEG to the detection and prediction of various degrees of brain fragility, depending on the depth of anesthesia (DoA).

Indices derived from the EEG signal, Spectral Edge Frequency 95 (SEF95), Patient State Index (PSI) and Bi-spectral Index (BIS) are now widely used in the operating room to monitor the Depth of Anesthesia (DoA). Recent studies suggest that variables extracted from per-operative EEG change as brain ages. A detailed reading of the quantitative EEG (qEEG) under GA has been recently described depending both on the specific drug used and patients' age. For GA induced with Propofol (2,6 di-isopropylphenol), a GABAergic receptor agonist used in Total Intra Venous Anesthesia (TIVA), the EEG signal under frontal derivations exhibits a specific signature characterized by a powerful alpha band. However, the elderly attenuates these EEG characteristics, which might be the results of a change in thalamic-cortical function and decreased neuronal excitability.

The goal of this observational clinical study is to assess the fragility of a patient under GA and based on the EEG SEF13 characteristics, weighted by the amount of Propofol administered.

Measures are based on EEG signal and subfrequency power spectral densities including alpha band as well as the amount of Propofol, each measured for EEG periods where SEF 95 = 8-13Hz.

Experimental design: This is a single-center, interventional, category I prospective study (minimal risks and constraints)

研究设计

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

入排标准

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

入选标准

  • •Patients > 18 years scheduled an elective interventional neuroradiology procedure or orthopedic surgery performed under general anesthesia.
  • •oral agreement obtained from each patient before anesthesia

排除标准

  • •age <18 years
  • •an emergency procedure

结局指标

主要结局

Propofol doses administered with Target Controlled Infusion (TCI in µg/ml)

时间窗: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]]

For all patients values of Target Controlled Infusion (TCI in µg/ml ) will be collected during Total Anesthesia Period (induction and hypnotic periods)

Values of Burst Suppression (in % of time) are collected from frontal electrodes montage (Fp1, Fp2, F7, F8)

时间窗: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]]

For all patients values of Burst Suppression (in % of time) will be collected during Total Anesthesia Period (induction and hypnotic periods)

Values of the Spectral Edge Frequency (SEF 95 in uV2/Hz) are collected from frontal electrodes montage (Fp1, Fp2, F7, F8)

时间窗: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]]

For all patients values of the Spectral Edge Frequency (SEF 95 in uV2/Hz) will be collected during Total Anesthesia Period (induction and hypnotic periods)

Values of Patient State Index (PSI-) are collected from frontal electrodes montage (Fp1, Fp2, F7, F8)

时间窗: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]]

For all patients values of Patient State Index (PSI -) will be collected during Total Anesthesia Period (induction and hypnotic periods)

次要结局

未报告次要终点

研究者

发起方
Joaquim MATEO
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joaquim MATEO

Clinical professor

Hopital Lariboisière

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