Quantitative EEG During Anesthesia Emergence in Children (qEEG)

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General; Child Behavior; Electroencephalography; Brain Waves; Psychology, Children

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Korea, Republic of
  • Nam-gu
    • Daegu, Nam-gu, Korea, Republic of, 42472
      • Eugene Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study collects subjects from a tertiary university hospital.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Yale preoperative anxiety score (mYPAS)	mYPAS is the assessment tool for measure the anxiety before induction. Higher score indicates higher anxiety.	before anesthesia induction (about 30 min before the surgery)
PAED score during PACU stay	On arrival at post-anesthesia care unit (PACU) and every 10 min from then, patients were checked 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.	During 60 min after PACU admission
FLACC score on initial, 10, 20, and 30 min	Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission	During 60 minutes after PACU admission]
Watcha scale on initial, 10, 20, and 30 min	On arrival and 10, 20, and 30 min after PACU admission, patients were checked Watcha scale as following 4-point scale; calm; crying, but can be consoled; Crying, cannot be consoled; Agitated and thrashing around Higher score indicates higher agitation.	During 60 minutes after PACU admission
Delta-theta to alpha-beta ratio (DTABR)	From the relative power of each brain waves, the investigators calculated the ratio as follows: DTABR = (Delta wave + Theta wave)/(alpha wave + beta wave)	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 relative power of each brain waves, the investigators calculated the ratio as follows: DAR = Delta wave / alpha wave	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 relative power of each brain waves, the investigators calculated the ratio as follows: TBR = Theta wave / beta wave	From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2019
• Primary Completion (ACTUAL): May 29, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: January 5, 2019
• First Submitted That Met QC Criteria: January 5, 2019
• First Posted (ACTUAL): January 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DCMC#7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No