Anesthetic Depth Using PLE (Phase Lag Entropy)
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- PLE (Phase Lag Entropy) value before and after intubation
研究概览
简要总结
The evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during propofol anesthesia
详细描述
The devices using EEG are commonly used for measuring the depth of consciousness during anesthesia. However, the existing devices are largely dependent on the biphasic analysis of 1-channel EEG signals, and thus do not provide proper information for anesthetic depth.
Recent study reported that the complexity or diversity of communication between the brain regions is related to the level of consciousness. In particular, during anesthesia, the phase synchronization (phase shift) between EEG signals at the front of the brain increases, indicating a reduction in communication diversity and a close relationship with loss of consciousness. Therefore, to predict the depth of sleep, a technique for precisely quantifying the complexity of inter-domain communication in the frontal brain is needed. Recently, PLEM™ (Inbody co., ltd, Republic of Korea), developed using the phase lag entropy (PLE), is a 4-channel EEG monitoring device that measures the entropy of the phase difference pattern between two channels of prefrontal and frontal brain. In addition, PLEM™ is able to observe changes in band power of EEG (Gamma, Beta, Alpha, Theta, and Delta waves). As the depth of anesthesia increases, the amplitude and frequency of EEG decreases. Generally, Beta waves (13-30 Hz) are seen in awake conscious patients and Alpha waves (8-12 Hz) are seen in patients resting with eyes closed. And Theta waves (4-7 Hz) and Delta waves (0-3 Hz) can be present in a patient who is sleeping or anesthetized.
The purpose of this study was to evaluate the efficacy for anesthetic depth monitoring of PLEM™ monitor during propofol anesthesia. The primary outcome of this study was to investigate the changes of PLE value and band power of EEG (Gamma, Beta, Alpha, Theta, Delta waves) on the PLEM™ monitor while varying the depth of anesthesia using propofol target controlled infusion (TCI) during anesthetic induction. The secondary outcomes of this study were to investigate whether the muscle relaxant affects the PLE value, and to compare the PLE values with BIS (bispectral index) (Aspect medical system, USA) that was the most widely used to measure the depth of anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients undergoing elective general anesthesia with American Society fo Anesthesiologist (ASA) physical status I or II (20-60 years)
排除标准
- •Patients with difficulty airway
- •Patients with cardiovascular disease
- •Patients with cerebrovascular disease
- •Patients with respiratory disease
研究组 & 干预措施
PLE (Phase Lag Entropy) monitoring
Investigators monitor the change of PLE value using the sensor of PLEM™ during propofol anesthesia.
干预措施: PLE (Phase Lag Entropy) (Device)
Muscle relaxant injection
Investigators monitor the change for PLE value using the sensor of PLEM™ before and after the injection of muscle relaxant.
干预措施: Muscle Relaxant (Drug)
结局指标
主要结局
PLE (Phase Lag Entropy) value before and after intubation
时间窗: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
Investigators measure the PLE value at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.
次要结局
- PLE value before and after the injection of muscle relaxant(at 3 min after the injection of muscle relaxant, immediately after intubation)
- PLE value and BIS value at that time of induction and awakening(at the time point of no-response to verbal command during induction (modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2, at the time point of response to verbal command during awakening (modified OAA/S scale = 3).)
- Bispectral index (BIS) value before and after intubation(at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation)
- Band power (Gamma, Beta, Alpha, Theta, and Delta waves) before and after intubation(at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation)
研究者
Hye-Won Shin
Department of Anesthesiology and Pain Medicine
Korea University Anam Hospital