Quantitative EEG During Anesthesia Emergence in Children

Anesthesia, General Clinical Trial

— qEEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797274
• Other study ID #: DCMC#7
• Status: Completed
• Start date: February 8, 2019
• Est. completion date: June 1, 2019

Study information

• Verified date: September 2019
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Korea, Republic of	Eugene Kim	Daegu	Nam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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
Secondary	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]
Secondary	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
Secondary	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
Secondary	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
Secondary	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