Quantitative EEG During Anesthesia Emergence in Children

NCT03797274 | Completed

• 1 other identifier: DCMC#7
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, General; Electroencephalography; Brain Waves; Psychology, Children; Child Behavior

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study collects subjects from a tertiary university hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (1)

Eugene Kim

Daegu, Nam-gu, 42472, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33010926 DERIVED

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eugene Kim, MD, PhD

  Assistant professor

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: January 9, 2019
• Study Start: February 8, 2019
• Primary Completion: May 29, 2019
• Study Completion: June 1, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

KR (1)