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临床试验/NCT05272202
NCT05272202招募中早期 1 期

Study of Modulations of Motor Brain Activity Following Stimulation of the Median Nerve During General Anesthesia

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
入组人数
30
试验地点
1
主要终点
Amplitude of the ERD (event-related desynchronization)/ERS (event- related synchronization)

研究概览

简要总结

Accidental Awareness during General Anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Actually, no monitoring techniques can accurately predict or detect an AAGA. Since the first reflex for a patient during an AAGA is to move, a brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. The investigators previously showed that median nerve stimulation (MNS) could be the keystone of a BCI specialized in the detection of movement intention. Indeed, based on these previous results, the investigators can envisage a routine system where the patient would be stimulated at the median nerve position, while a BCI device would analyze the event-related desynchronization (ERD) and event-related synchronization (ERS) modulations in the motor cortex to check whether the patient is intending to move or not. According to the investigator's knowledge, no published studies have investigated the detection of 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 ERD and ERS 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 in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. Changes in ERD and ERS during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. Pre- and post-injection comparisons of propofol will be performed by paired series tests. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 81 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients >18 years and <81 years
  • Right-handed
  • Programmed for surgery with the use of an intravenous anesthesia with a propofol concentration objective

排除标准

  • Allergy to propofol, soy or peanuts
  • BMI<20 or >30
  • Pregnant or breastfeeding women
  • Adult unable to give consent
  • Medical or surgical history that may interfere with median nerve stimulation or the obtention of the EEG signal (for example: diabetes, polyneuropathy, central neurodegenerative disease, epilepsy, brain surgery)
  • History of right median nerve injury
  • Amputation of the upper right limb
  • Impossibility of affixing an EEG helmet
  • Addiction

研究组 & 干预措施

Median nerve stimulation

Experimental

干预措施: Propofol (Drug)

Median nerve stimulation

Experimental

干预措施: Median nerve stimulation (Device)

Median nerve stimulation

Experimental

干预措施: EEG measurements (Device)

结局指标

主要结局

Amplitude of the ERD (event-related desynchronization)/ERS (event- related synchronization)

时间窗: From the time each stimulation is performed until 4 seconds after the stimulation is completed.

The main evaluation outcome will be the amplitude of the ERD (event-related desynchronization)/ERS (event- related synchronization) after median nerve stimulation, within 4 s of the stimulation, at various propofol concentrations. This amplitude will be calculated using a baseline taken before each stimulation. The amplitudes of the ERD and ERS will be extracted. The ERDs and ERSs will be displayed from the time each stimulation is performed until 4 s after the stimulation is completed.

次要结局

  • Detection of ERD patterns via new machine-learning algorithms (percent of correct detection)(From the time each stimulation is performed until 4 seconds after the stimulation is completed.)
  • Modulation of ERD patterns by anesthetics drugs. Percentage of variation in amplitude.(From the time each stimulation is performed until 4 seconds after the stimulation is completed.)
  • Detection of ERS patterns via new machine-learning algorithms (percentage of correct detection)(From the time each stimulation is performed until 4 seconds after the stimulation is completed.)
  • Modulation of ERS patterns by anesthetics drugs via new machine-learning algorithms (percentage change in amplitude)(From the time each stimulation is performed until 4 seconds after the stimulation is completed.)

研究者

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

Denis SCHMARTZ

Head of anesthesiology department

Brugmann University Hospital

研究点 (1)

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