Rimbert Sébastien, Lelarge Julien, Guerci Philippe, Bidgoli Seyed Javad, Meistelman Claude, Cheron Guy, Cebolla Alvarez Ana Maria, Schmartz Denis
CHU Brugmann, Université Libre de Bruxelles, Bruxelles, Belgium.
Laboratory of Neurophysiology and Movement Biomechanics, Université Libre de Bruxelles Neurosciences Institute, Bruxelles, Belgium.
JMIR Res Protoc. 2023 Feb 2;12:e43870. doi: 10.2196/43870.
Accidental awareness during general anesthesia (AAGA) is defined as an unexpected awareness of the patient during general anesthesia. This phenomenon occurs in 1%-2% of high-risk practice patients and can cause physical suffering and psychological after-effects, called posttraumatic stress disorder. In fact, no monitoring techniques are satisfactory enough to effectively prevent AAGA; therefore, new alternatives are needed. Because the first reflex for a patient during an AAGA is to move, but cannot do so because of the neuromuscular blockers, we believe that it is possible to design a brain-computer interface (BCI) based on the detection of movement intention to warn the anesthetist. To do this, we propose to describe and detect the changes in terms of motor cortex oscillations during general anesthesia with propofol, while a median nerve stimulation is performed. We believe that our results could enable the design of a BCI based on median nerve stimulation, which could prevent AAGA.
To our knowledge, no published studies have investigated the detection of electroencephalographic (EEG) patterns in relation to peripheral nerve stimulation over the sensorimotor cortex during general anesthesia. The main objective of this study is to describe the changes in terms of event-related desynchronization and event-related synchronization modulations, in the EEG signal over the motor cortex during general anesthesia with propofol while a median nerve stimulation is performed.
STIM-MOTANA is an interventional and prospective study conducted with patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation at two different times: (1) when the patient is awake before surgery (2) and under general anesthesia. A total of 30 patients will receive surgery under complete intravenous anesthesia with a target-controlled infusion pump of propofol.
The changes in event-related desynchronization and event-related synchronization during median nerve stimulation according to the various propofol concentrations for 30 patients will be analyzed. In addition, we will apply 4 different offline machine learning algorithms to detect the median nerve stimulation at the cerebral level. Recruitment began in December 2022. Data collection is expected to conclude in June 2024.
STIM-MOTANA will be the first protocol to investigate median nerve stimulation cerebral motor effect during general anesthesia for the detection of intraoperative awareness. Based on strong practical and theoretical scientific reasoning from our previous studies, our innovative median nerve stimulation-based BCI would provide a way to detect intraoperative awareness during general anesthesia.
Clinicaltrials.gov NCT05272202; https://clinicaltrials.gov/ct2/show/NCT05272202.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/43870.
全身麻醉期间的意外知晓（AAGA）被定义为患者在全身麻醉期间意外的知晓。这种现象发生在1%-2%的高风险手术患者中，可导致身体痛苦和心理后遗症，即创伤后应激障碍。事实上，目前尚无足够令人满意的监测技术能有效预防AAGA；因此，需要新的替代方法。由于患者在AAGA期间的第一反应是移动，但因神经肌肉阻滞剂而无法移动，我们认为有可能设计一种基于运动意图检测的脑机接口（BCI）来警告麻醉师。为此，我们建议描述并检测在丙泊酚全身麻醉期间进行正中神经刺激时运动皮层振荡的变化。我们相信我们的结果能够促成基于正中神经刺激的BCI的设计，从而预防AAGA。
据我们所知，尚无已发表的研究探讨全身麻醉期间与感觉运动皮层外周神经刺激相关的脑电图（EEG）模式检测。本研究的主要目的是描述在丙泊酚全身麻醉期间进行正中神经刺激时，运动皮层EEG信号中与事件相关去同步化和事件相关同步化调制相关的变化。
STIM-MOTANA是一项针对计划接受全身麻醉手术患者的干预性前瞻性研究，包括在两个不同时间进行EEG测量和正中神经刺激：（1）患者手术前清醒时，（2）全身麻醉状态下。共有30例患者将接受丙泊酚靶控输注泵全凭静脉麻醉下的手术。
将分析30例患者在不同丙泊酚浓度下正中神经刺激期间事件相关去同步化和事件相关同步化的变化。此外，我们将应用4种不同的离线机器学习算法在大脑层面检测正中神经刺激。招募工作于2022年12月开始。数据收集预计于2024年6月结束。
STIM-MOTANA将是首个研究全身麻醉期间正中神经刺激对大脑运动效应以检测术中知晓的方案。基于我们先前研究强有力的实践和理论科学推理，我们创新的基于正中神经刺激的BCI将提供一种检测全身麻醉期间术中知晓的方法。
Clinicaltrials.gov NCT05272202；https://clinicaltrials.gov/ct2/show/NCT05272202。
国际注册报告识别码（IRRID）：PRR1-10.2196/43870。
