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临床试验/NCT05654311
NCT05654311招募中不适用

The Relationship Between Emergence Agitation and Electroencephalogram in Young Adults Undergoing Nasal Surgery Under General Anesthesia

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年1月2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
55
试验地点
1
主要终点
EEG band relative power measured in the frontal lobe

研究概览

简要总结

The purpose of the study is to evaluate the relationship between perioperative electroencephalogram and emergence agitation in the nasal surgery. Previous studies showed that low frequency band wave activity increased during emergence delirium in pediatric patients. It is still not enough to explain the relationship between emergence agitation and electroencephalogram in adults. Researchers will demonstrate the relationship between parameters related electroencephalogram and emergence agitation in adults undergoing nasal surgery.

详细描述

Researchers use Sedline to perform perioperative EEG measurements of young adult patients undergoing nasal surgery under general anesthesia with sevoflurane. Emergence agitation occurrence and EEG patterns are observed.

The researchers record the patient's sex, type of surgery, pre-education on emergence agitation, preoperative hospital anxiety and depression scale (HADS), postoperative pain, amount of analgesics administered in the surgery/recovery room, and PACU time. Investigators check the correlation between EEG and perioperative variables. Investigators also compare EEG and perioperative variables for those who were given an explanation of emergence agitation and those who were not.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 19-55 years who are undergoing nasal surgery under general anesthesia using inhalational agent

排除标准

  • CNS disease (ex.dementia, stroke, brain tumor, psychological disorder..)
  • unable to communicate
  • general anesthesia history within 6 months
  • disagree to participate in study

结局指标

主要结局

EEG band relative power measured in the frontal lobe

时间窗: From the cessation of sevoflurane inhalation to the extubation of tracheal tubes

relative power of each brain waves : Original frontal EEG waves using 4 channel sedline (Masimo, Irvine, CA, USA) sensor will processed by FFT(fast Fourier transform). Each band is as follows.: Delta: 1-4 Hz Theta: 4-8 Hz Alpha: 8-13 Hz Beta: 13-30 Hz.

occurrence of emergence agitation

时间窗: From the cessation of sevoflurane inhalation to transfer to the recovery room

Emergence agitation occurrence : RASS(Richmond Agitation Sedation Score) is 10 scaled (-5\~+4) score to assess sedation/agitation level; 0 is a calm state, and a value less than 0 means a sedation state.

次要结局

  • HADS (Hospital Anxiety and Depression Scale)(1 day before surgery (after admission))
  • Effect of preoperative education on emergence agitation(up to 6 months after completion of the study)
  • VAS (Visual Analogue Scale)(during 30 minutes after PACU admission)

研究者

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

Young Song

Associate Professor

Gangnam Severance Hospital

研究点 (1)

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