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临床试验/NCT05818163
NCT05818163招募中不适用

Association of Perioperative Electroencephalography Spectral Analysis With Postoperative Complications

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
pain in the postanesthesia care unit

研究概览

简要总结

Using data from electroencephalogram (EEG) obtained through intraoperative depth of anesthesia monitoring devices, combined with clinical symptoms such as postoperative pain and delirium, investigate their correlation and verify whether intraoperative EEG spectral analysis can predict the occurrence of postoperative pain, nausea and vomiting, restlessness, or delirium in patients undergoing surgery.

详细描述

Due to the complexity of the original EEG waveforms, previous anesthesia depth monitoring systems only calculated a single index, such as Bispectral index (BIS) or patient state index (PSI), to determine the state under anesthesia. However, a single numerical change may not reflect the true state under anesthesia. By analyzing the original EEG waveforms, more information can be obtained, such as density spectral array (DSA) and power spectral density, which can quantify the energy distribution at various brain wave frequencies. This allows anesthesiologists to determine the effects of medication on brain waves and the effects of surgical stimulation on brain waves during surgery.

After obtaining the signed informed consent form, before inducing general anesthesia in the patient entering the operating room, an anesthesia depth monitoring patch is attached to the forehead, and EEG data during anesthesia is collected using the currently used anesthesia depth monitoring device. The monitoring process starts from the beginning of general anesthesia until the end of the surgery, and the EEG recording is stopped only when the patient wakes up from general anesthesia and leaves the operating room.

By using the original EEG during anesthesia depth monitoring to conduct spectral analysis and combining it with common post-anesthesia adverse symptoms such as pain, nausea and vomiting, delirium, and restlessness, a correlation analysis is conducted between the quantified EEG values and postoperative symptoms. This verifies whether intraoperative EEG spectral analysis can predict the occurrence of postoperative complications.

研究设计

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

入排标准

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

入选标准

  • Aged 20 years or older.
  • Patients who received general anesthesia within the our hospital system.

排除标准

  • Individuals with suspected infections, such as a fever higher than 38.3℃
  • Individuals with renal dysfunction, such as those with creatinine levels higher than 1.5 or those who require long-term dialysis
  • Individuals with cardiac dysfunction, such as those with NYHA class III or higher heart failure or coronary heart disease Individuals with neurological diseases, such as those with brain tumors, dementia, stroke, or epilepsy
  • Vulnerable populations, such as minors (under 20 years of age), pregnant women and fetuses, prisoners, adults who cannot give informed consent, individuals with disabilities, individuals with mental illness, residents of nursing homes or long-term care facilities, or those who may be subject to coercion or unable to make decisions freely.

结局指标

主要结局

pain in the postanesthesia care unit

时间窗: up to 2 hours, postanesthesia

Visual Analog Scale (VAS) \> 3 in the postanesthesia care unit

agitation in the postanesthesia care unit

时间窗: up to 2 hours, postanesthesia

Richmond Agitation-Sedation Scale (RASS)\>2 in the postanesthesia care unit

次要结局

  • delirium(up to 2 days, postanesthesia)
  • nausea and vomiting(up to 1 day, postanesthesia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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