Quantitative EEG During Anesthesia Emergence in Children (qEEG)
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|ClinicalTrials.gov Identifier: NCT03797274|
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : February 12, 2019
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.
|Condition or disease|
|Anesthesia, General Electroencephalography Brain Waves Psychology, Children Child Behavior|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Quantitative Frontal Electroencephalography (EEG) and Postoperative Emergence Delirium Following General Anesthesia in Children: a Prospective Observational Study|
|Actual Study Start Date :||February 8, 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
- Occurrence of Emergence delirium [ Time Frame: 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.
- Relative power of each brain waves [ Time Frame: 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 anesthesia period. The EEG is then segmented into 30s 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 : 0.1-4 Hz Theta: 4-9 Hz Alpha: 9-12 Hz Beta: 12-30 Hz Gamma: 30-60 Hz
And then, the relative power of each frequency bands to the total power of the sum is calculated.
- modified Yale preoperative anxiety score (mYPAS) [ Time Frame: 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.
- PAED score during PACU stay [ Time Frame: 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 [ Time Frame: During 60 minutes after PACU admission] ]Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
- Watcha scale on initial, 10, 20, and 30 min [ Time Frame: 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
- crying, but can be consoled
- Crying, cannot be consoled
- Agitated and thrashing around
Higher score indicates higher agitation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797274
|Contact: Eugene Kim, MD, PhDfirstname.lastname@example.org|
|Contact: JongHae Kim, MDemail@example.com|
|Korea, Republic of|
|Daegu, Nam-gu, Korea, Republic of, 42472|
|Contact: Eugene Kim, MD, PhD 82536503265 firstname.lastname@example.org|
|Contact: JongHae Kim, MD 82536504979 email@example.com|
|Principal Investigator: Eugene Kim, MD, PhD|
|Sub-Investigator: JongHae Kim, MD|
|Study Chair:||Eugene Kim, MD, PhD||Assistant professor|