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Effectiveness of Electroencephalography Guided Anesthesia (EEG Anesthesia)

2026年4月30日 更新者:David R. Drover、Stanford University

A Pilot Study to Evaluate the Feasibility of EEG-guided Anesthesia Protocol to Reduce POD

This study will use brain wave information, known as electroencephalography (EEG), to help guide anesthesia delivery during surgery. It is believed that the use of EEG has the potential to reduce postoperative delirium - a common side effect of general anesthesia. Postoperative delirium is known to cause long lasting cognitive deficits and increase the chance of developing dementia in geriatric patients. This study aims to reduce these risks posed by modern day anesthesia practices through more efficient delivery of anesthesia utilizing brain wave activity information.

研究概览

研究类型

介入性

注册 (估计的)

225

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Ariel Clinical Research Coordinator Associate
  • 电话号码:650-724-3021
  • 邮箱:arielkay@stanford.edu

研究联系人备份

  • 姓名:Maya Clinical Research Coordinator Associate
  • 电话号码:650-724-2620
  • 邮箱:mcaple@stanford.edu

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

Part A Inclusion Criteria:

  • Signed and dated informed consent form prior to any study-specific procedures.
  • Willingness and ability to comply with all study procedures and availability for the duration of the study, including all scheduled assessments and follow-up visits.
  • Currently practicing anesthetic provider, defined as either:

    • Attending anesthesiologist, or
    • Certified Registered Nurse Anesthetist (CRNA).
  • Limited prior formal training in EEG interpretation for anesthetic depth, as self-reported by the participant (see Exclusion Criteria for details).
  • Fluent in English, to ensure comprehension of study materials and assessments.
  • Able to access and utilize required technology (e.g., computer or tablet with internet access) for completion of digital modules and online assessments.
  • In good general health and capable of fulfilling clinical duties, as self-reported and confirmed by site investigator review.
  • Willingness to be randomized to any of the study arms and to participate in all assigned educational interventions and assessments.
  • Willingness to adhere to the protocol-specified anesthetic management strategy during the real-case assessments.

Part B Inclusion Criteria:

  • Provides written, signed informed consent prior to the surgical procedure.
  • Is age 60 years or older.
  • Is scheduled to undergo an elective, non-cardiac, non-neurologic surgical procedure expected to last at least two hours.
  • Is planned to receive general anesthesia.
  • Has an American Society of Anesthesiologists (ASA) physical status of I, II, or III.
  • Has intact skin on the forehead suitable for the application of EEG electrodes.

Exclusion Criteria:

Part A Exclusion Criteria:

  • Fellowship training in neuroanesthesia or neurocritical care.
  • Participation in EEG-related research or formal EEG training within the past 12 months.
  • Inability to access or utilize required technology (e.g., computer or tablet with internet access) necessary for completion of digital modules and online assessments.
  • Any condition (physical, psychological, or cognitive) that, in the opinion of the site investigator, would preclude full participation in study activities or completion of the study protocol.
  • Known allergy or sensitivity to materials used in EEG electrodes (e.g., adhesives or gels), if applicable.
  • Non-practicing anesthetic providers (e.g., retired, not currently providing clinical care).

Part B Exclusion Criteria:

  • Is unable to provide legally effective informed consent.
  • Is scheduled for emergency, cardiac, or neurologic surgery.
  • Has an American Society of Anesthesiologists (ASA) physical status of IV or greater.
  • Has a pre-existing diagnosis of dementia, significant cognitive impairment, or other major neurologic disease (e.g., epilepsy, Parkinson's disease).
  • Has a known allergy to the adhesives or gels used with EEG electrodes.
  • Has a condition, such as a craniofacial deformity or skin condition on the forehead, that would prevent proper placement or functioning of the EEG monitor.
  • Currently pregnant.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Part A: Anesthesia Providers that Receive Training
Eligible anesthesia providers that include both anesthesiologists and CRNAs who will receive an EEG-guided anesthesia training program for anesthesia providers.
The EEG-guided anesthesia training session for the anesthesia providers will administer simulation-based assessments at baseline, immediately post-intervention, and at one, three, and six month follow-up time points to track provider competency in EEG interpretation and anesthetic titration.
无干预:Part A: Anesthesia Providers that Do Not Receive Training
Eligible anesthesia providers that include both anesthesiologists and CRNAs who will did not receive an EEG-guided anesthesia training program for anesthesia providers.
其他:Part B: All Participants Receive the EEG-Guided Intervention
Part B will be a prospective, single-arm pilot study. As a result, randomization of patients into different groups will not occur, and all patients will receive the EEG-guided intervention. Blinding of the intraoperative clinical team is also not feasible in this case, as providers must be aware of all monitoring tools in use. Instead, this study will mitigate potential for bias by utilizing blinded outcome assessors. Researchers will be kept separate from the intraoperative care team to remain unaware of specific details of the patient's anesthetic course.
All surgical patients in Part B of the study will receive EEG-guided anesthesia. EEG data collected from patient participants will be provided as live data during their surgical procedures to the anesthesia provider. Anesthesia providers may use this data to assist their decision-making on anesthetic delivery.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Minimum Alveolar Concentration (MAC)
大体时间:Intra-operative phase of care of participant.
The primary endpoint is the total intraoperative anesthetic exposure. This will be measured as the time-weighted average of the age-adjusted Minimum Alveolar Concentration (MAC) of volatile anesthetic administered during the maintenance phase of anesthesia. These data will be collected directly from the electronic anesthetic record for each enrolled patient case and will be reviewed and verified by the study team.
Intra-operative phase of care of participant.

次要结果测量

结果测量
措施说明
大体时间
3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
大体时间:Postoperative Days 1 to 3.
To gather data for POD progression modeling, patients will be assessed for delirium daily for the first three postoperative days using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM). These assessments will be performed by trained research staff who are blinded to the patient's treatment group.
Postoperative Days 1 to 3.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2031年1月1日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月30日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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