qEEG
Quantitative Frontal Electroencephalography (EEG) and Postoperative Emergence Delirium Following General Anesthesia in Children: a Prospective Observational Study
Sponsor study identifier
observational
60
1 country
1
Study Start
February 8, 2019
Actual (reported)Primary Completion
May 29, 2019
Actual (reported)Study Completion
June 1, 2019
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 5, 2019
Actual (reported)January 9, 2019
Actual (reported)February 8, 2019
Actual (reported)May 29, 2019
Actual (reported)June 1, 2019
Actual (reported)Occurrence of Emergence delirium
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.
During 60 minutes after PACU admission
Relative power of each brain waves
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.
From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
This study collects subjects from a tertiary university hospital.
Eugene Kim
Daegu, Nam-gu, 42472, South Korea
Kim J, Lee HC, Byun SH, Lim H, Lee M, Choung Y, Kim E. Frontal electroencephalogram activity during emergence from general anaesthesia in children with and without emergence delirium. Br J Anaesth. 2021 Jan;126(1):293-303. doi: 10.1016/j.bja.2020.07.060. Epub 2020 Oct 1.
Eugene Kim, MD, PhD
Assistant professor
60 participants (actual enrollment reported by the registry).
First Submitted
January 5, 2019
First Posted
January 9, 2019
Study Start
February 8, 2019
Actual (reported)Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia
modified Yale preoperative anxiety score (mYPAS)
before anesthesia induction (about 30 min before the surgery)
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]
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
Contact the study team to confirm eligibility.
Primary Completion
May 29, 2019
Actual (reported)Study Completion
June 1, 2019
Actual (reported)Last Updated
September 4, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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