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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
Sponsor:
Information provided by (Responsible Party):
Eugene Kim, Daegu Catholic University Medical Center

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.


Condition or disease
Anesthesia, General Electroencephalography Brain Waves Psychology, Children Child Behavior

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

    1. calm
    2. crying, but can be consoled
    3. Crying, cannot be consoled
    4. Agitated and thrashing around

    Higher score indicates higher agitation.




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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study collects subjects from a tertiary university hospital.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Eugene Kim, MD, PhD 82-53-650-3265 tomomie@hanmail.net
Contact: JongHae Kim, MD 82-53-650-4979 usmed@cu.ac.kr

Locations
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Korea, Republic of
Eugene Kim Recruiting
Daegu, Nam-gu, Korea, Republic of, 42472
Contact: Eugene Kim, MD, PhD    82536503265    tomomie@hanmail.net   
Contact: JongHae Kim, MD    82536504979    usmed@cu.ac.kr   
Principal Investigator: Eugene Kim, MD, PhD         
Sub-Investigator: JongHae Kim, MD         
Sponsors and Collaborators
Daegu Catholic University Medical Center
Investigators
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Study Chair: Eugene Kim, MD, PhD Assistant professor

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Responsible Party: Eugene Kim, Assistant professor, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT03797274     History of Changes
Other Study ID Numbers: DCMC#7
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No