Quantitative EEG During Anesthesia Emergence in Children

Completed

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

• Registration Number: NCT03797274
• Lead Sponsor: Daegu Catholic University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-05
• Study First Submitted QC: 2019-01-05
• Study First Posted: 2019-01-09
• Study Start: 2019-02-08
• Primary Completion: 2019-05-29
• Study Completion: 2019-06-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative power of each brain waves	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	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 Outcome Measures

Name	Time	Method
PAED score during PACU stay	During 60 min after PACU admission	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.
FLACC score on initial, 10, 20, and 30 min	During 60 minutes after PACU admission]	Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
modified Yale preoperative anxiety score (mYPAS)	before anesthesia induction (about 30 min before the surgery)	mYPAS is the assessment tool for measure the anxiety before induction. Higher score indicates higher anxiety.
Watcha scale on initial, 10, 20, and 30 min	During 60 minutes after PACU admission	On arrival and 10, 20, and 30 min after PACU admission, patients were checked Watcha scale as following 4-point scale; 1. calm; 2. crying, but can be consoled; 3. Crying, cannot be consoled; 4. Agitated and thrashing around; Higher score indicates higher agitation.
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	From the relative power of each brain waves, the investigators calculated the ratio as follows: DTABR = (Delta wave + Theta wave)/(alpha wave + beta wave)
Delta to alpha ratio	From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway	From the relative power of each brain waves, the investigators calculated the ratio as follows: DAR = Delta wave / alpha wave
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	From the relative power of each brain waves, the investigators calculated the ratio as follows: TBR = Theta wave / beta wave

Trial Locations

Locations (1)

Eugene Kim; 🇰🇷 Daegu, Nam-gu, Korea, Republic of