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Completed

NCT Number: NCT03797274

Quantitative EEG During Anesthesia Emergence in Children

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.

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Key information

Conditions

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

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eugene Kim

Daegu, Nam-gu, 42472, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 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.

Secondary outcomes

  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

    • calm
    • crying, but can be consoled
    • Crying, cannot be consoled
    • Agitated and thrashing around

    Higher score indicates higher agitation.

  5. Delta-theta to alpha-beta ratio (DTABR)

    Time frame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway

    From the relative power of each brain waves, the investigators calculated the ratio as follows:

    DTABR = (Delta wave + Theta wave)/(alpha wave + beta wave)

  6. Delta to alpha ratio

    Time frame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway

    From the relative power of each brain waves, the investigators calculated the ratio as follows:

    DAR = Delta wave / alpha wave

  7. Theta to beta ratio (TBR)

    Time frame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway

    From the relative power of each brain waves, the investigators calculated the ratio as follows:

    TBR = Theta wave / beta wave

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

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

Acronym: qEEG

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2019
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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