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Clinical Trials/NCT03797274
NCT03797274
Completed
Not Applicable

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

Daegu Catholic University Medical Center1 site in 1 country60 target enrollmentFebruary 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, General
Sponsor
Daegu Catholic University Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Relative power of each brain waves
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 8, 2019
End Date
June 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Daegu Catholic University Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Eugene Kim

Assistant professor

Daegu Catholic University Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Relative power of each brain waves

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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