Anesthesia, GeneralqEEGNCT03797274
Quantitative EEG During Anesthesia Emergence in Children
An observational study of Anesthesia, General and Electroencephalography, run by Daegu Catholic University Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Anesthesia, General, Electroencephalography, Brain Waves
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Feb 2019to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: This study collects subjects from a tertiary university hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Frontal Electroencephalography (EEG) and Postoperative Emergence Delirium Following General Anesthesia in Children: a Prospective Observational Study
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.
- Conditions
- Anesthesia, General, Electroencephalography, Brain Waves, Psychology, Children, Child Behavior
- Medical subject headings
- Child Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 60 minutes after PACU admission
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.
Measured: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
Secondary outcomes (7)
modified Yale preoperative anxiety score (mYPAS)
mYPAS is the assessment tool for measure the anxiety before induction. Higher score indicates higher anxiety.
Measured: before anesthesia induction (about 30 min before the surgery)
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.
Measured: During 60 min after PACU admission
FLACC score on initial, 10, 20, and 30 min
Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
Measured: During 60 minutes after PACU admission]
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.
Measured: During 60 minutes after PACU admission
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)
Measured: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
Delta to alpha ratio
From the relative power of each brain waves, the investigators calculated the ratio as follows:
DAR = Delta wave / alpha wave
Measured: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
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
Measured: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start8 Feb 2019
- Primary completion29 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Kim, Daegu Catholic University Medical Center
- Investigators
- Eugene Kim, MD, PhD, Study chair, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797274
- Sponsor's protocol ID
- DCMC#7
- Acronym
- qEEG
- Status last verified
- Sep 2019
- First submitted
- 5 Jan 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim J, Lee HC, Byun SH, Lim H, Lee M, Choung Y, Kim E. Frontal electroencephalogram activity during emergence from general anaesthesia in children with and without emergence delirium. Br J Anaesth. 2021 Jan;126(1):293-303. doi: 10.1016/j.bja.2020.07.060. Epub 2020 Oct 1.
PubMed 33010926
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Frontal Electroencephalography (EEG) and Postoperative Emergence Delirium Following General Anesthesia in Children: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03797274
- Acronym / sponsor ID
- qEEG / DCMC#7
- Conditions
- Anesthesia, General, Electroencephalography, Brain Waves, Psychology, Children, Child Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study collects subjects from a tertiary university hospital.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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.
7 secondary outcomes
modified Yale preoperative anxiety score (mYPAS)
Time frame: before anesthesia induction (about 30 min before the surgery)
PAED score during PACU stay
Time frame: During 60 min after PACU admission
FLACC score on initial, 10, 20, and 30 min
Time frame: During 60 minutes after PACU admission]
Watcha scale on initial, 10, 20, and 30 min
Time frame: During 60 minutes after PACU admission
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Derived from this study: PubMed 33010926Kim J, Lee HC, Byun SH, Lim H, Lee M, Choung Y, Kim E. Frontal electroencephalogram activity during emergence from general anaesthesia in children with and without emergence delirium. Br J Anaesth. 2021 Jan;126(1):293-303. doi: 10.1016/j.bja.2020.07.060. Epub 2020 Oct 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Kim, MD, PhD study chair
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General and Electroencephalography, run by Daegu Catholic University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Emergence delirium (time frame: During 60 minutes after PACU admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.