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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03797274
Other study ID # DCMC#7
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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 VISTAâ„¢, 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
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