跳至主要内容
临床试验/NCT03797274
NCT03797274已完成不适用

Quantitative Frontal Electroencephalography (EEG) and Postoperative Emergence Delirium Following General Anesthesia in Children: a Prospective Observational Study

Daegu Catholic University Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Relative power of each brain waves

研究概览

简要总结

Most drugs used in general anesthesia work on various receptors in the human brain, causing unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system. After the anesthesia, baseline physiological function will be attained by administration of some reversal drugs or as the time goes by. In this process, various side effects may occur.

Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia in children and that can cause several problems during the recovery period. Previous EEG studies reported that this phenomenon is related to hyperexcitation of the brain, and occurrence of epileptiform discharges during anesthesia induction may indicate an increased vulnerability for the development of a functional brain disorder in these children.

However, to the best of our knowledge, there is no studies concern evaluating quantitative EEG parameters for prediction of this postoperative negative behavior in children.

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
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 2 and 10 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive surgery under general anesthesia

排除标准

  • If the guardian and the subject are difficult to evaluate normally due to language barriers/language disorders/delay or autistic disorder
  • with developmental delay, neurological disorders or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances, etc
  • refusal of consent
  • Recent history (within a month) of received general anesthesia or surgery
  • presence of congenital or other genetic conditions thought to influence brain development

结局指标

主要结局

Relative power of each brain waves

时间窗: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway

Original frontal EEG segments are attained via 2 channel bispectral index monitoring (BIS VISTA™, Aspect Medical Systems, Inc. MA, USA) during the anesthesia period. The EEG is then segmented into 4 s epochs and fast Fourier transform (FFT) analysis is performed for each of these segments. FFT of all these selected EEG segments are computed in the following frequency bands: Delta: 1-4 Hz Theta: 4-8 Hz Alpha: 8-13 Hz Beta: 13-30 Hz And then, the relative power of each frequency bands to the total power of the sum is calculated.

Occurrence of Emergence delirium

时间窗: During 60 minutes after PACU admission

On arrival at post-anesthesia care unit (PACU), patients are checked post-anesthesia emergence delirium (PAED). The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity. If the PAED score is greater than 12, investigators define emergence delirium.

次要结局

  • PAED score during PACU stay(During 60 min after PACU admission)
  • FLACC score on initial, 10, 20, and 30 min(During 60 minutes after PACU admission])
  • modified Yale preoperative anxiety score (mYPAS)(before anesthesia induction (about 30 min before the surgery))
  • Watcha scale on initial, 10, 20, and 30 min(During 60 minutes after PACU admission)
  • Delta-theta to alpha-beta ratio (DTABR)(From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway)
  • Delta to alpha ratio(From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway)
  • Theta to beta ratio (TBR)(From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway)

研究者

发起方
Daegu Catholic University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eugene Kim

Assistant professor

Daegu Catholic University Medical Center

研究点 (1)

Loading locations...

相似试验