Clinical trial NCT03797274: Quantitative EEG During Anesthesia Emergence in Children
Official title: Quantitative Frontal Electroencephalography (EEG) and Postoperative Emergence Delirium Following General Anesthesia in Children: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Electroencephalography
Brain Waves
Psychology, Children
Child Behavior
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study collects subjects from a tertiary university hospital.

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.


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

Primary outcomes:
measure: Occurrence of Emergence delirium
timeFrame: During 60 minutes after PACU admission
measure: Relative power of each brain waves
timeFrame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
Secondary outcomes:
measure: modified Yale preoperative anxiety score (mYPAS)
timeFrame: before anesthesia induction (about 30 min before the surgery)
measure: PAED score during PACU stay
timeFrame: During 60 min after PACU admission
measure: FLACC score on initial, 10, 20, and 30 min
timeFrame: During 60 minutes after PACU admission]
measure: Watcha scale on initial, 10, 20, and 30 min
timeFrame: During 60 minutes after PACU admission
measure: Delta-theta to alpha-beta ratio (DTABR)
timeFrame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
measure: Delta to alpha ratio
timeFrame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
measure: Theta to beta ratio (TBR)
timeFrame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Eugene Kim
state: Nam-gu
Study officials:
affiliation: Assistant professor
name: Eugene Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.