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临床试验/NCT06342570
NCT06342570招募中不适用

Quantitative Analysis of EEG Changes in Response to Nociception

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2024年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
109
试验地点
1
主要终点
Correlation between changes in ANI and EEG band power in response to surgical stimulation.

研究概览

简要总结

This study will quantify the nociception using Analgesia Nociception Index (ANI) during general anesthesia and analyze the differences in EEG depending on the degree of nociception. Additionally, the investigators will quantify the nociception during recovery and analyze the differences in EEG depending on the degree of nociception.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥ 19 undergoing laparoscopic surgery

排除标准

  • Patients with arrhythmia
  • Patients with pacemaker implantation
  • Patients who have received a heart transplant
  • Patients taking medications that may affect ANI (antimuscarinics, alpha-agonist, beta blockers, etc.)
  • Patients with central nervous system disease (dementia, stroke, epilepsy, brain tumor, psychiatric disease, etc.)
  • Patients who cannot understand the consent form

结局指标

主要结局

Correlation between changes in ANI and EEG band power in response to surgical stimulation.

时间窗: When the laparoscope is inserted

Correlation between changes in ANI and EEG band power in response to surgical stimulation

次要结局

  • Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration(When analgesic drug is administered in the PACU.)
  • Correlation between changes in ANI and EEG band power in response to tracheal intubation(When the tracheal intubation is conducted)
  • Correlation between changes in ANI and EEG connectivity in response to surgical stimulation(When the laparoscope is inserted)
  • Correlation between changes in ANI and EEG connectivity in response to tracheal intubation(When the tracheal intubation is conducted)
  • Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration(When analgesic drug is administered in the PACU.)
  • Differences in EEG connectivity during recovery between groups with large and small changes in ANI(From admission to the PACU to discharge from the PACU)
  • Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI(From the beginning of surgery to the end of surgery)
  • Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI(From admission to the PACU to discharge from the PACU)
  • Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic(From the beginning of surgery to the end of surgery)
  • Differences in EEG connectivity during surgery between groups with large and small changes in ANI(From the beginning of surgery to the end of surgery)
  • Differences in EEG connectivity depending on the type of inhaled anesthetic(From the beginning of surgery to the end of surgery)
  • Differences in ANI depending on the type of inhaled anesthetic(From the beginning of surgery to the end of surgery)

研究者

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

Dong Woo Han

Professor

Gangnam Severance Hospital

研究点 (1)

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