Emergence DeliriumNCT05800639
Frontal Alpha Asymmetry and Pediatric Emergence Delirium
An observational study of Emergence Delirium, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
This study aimed to investigate whether the association between the preoperative anxiety level and emergence delirium involves EEG frontal alpha asymmetry in pediatric patients undergoing ophthalmic surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Ophthalmic surgery and General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Apr 2023to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 2-8 year with an American Society of Anesthesiologists (ASA) physical status of I-II who are undergoing elective ophthalmological requiring general anesthesia in Gangnam Severance Hospital will be eligible.
Who may be able to join
- Children aged 2-8 year
- Children with an American Society of Anesthesiologists (ASA) physical status of I-II
- Children who are scheduled to undergo elective ophthalmological requiring general anesthesia
Who cannot join
- Emergency surgery
- Patients with developmental delays
- Patients with neurological or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances
- Patients with autism
- Patients with a recent history (within one month) of receiving general anesthesia
- Patients with congenital or genetic diseases that may influence brain development
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
Sun-Kyung Park, 82-2-2019-4601, mayskpark@gmail.com
Young Song
About this study
Official title: Mediation Role of Perioperative Electroencephalogram Frontal Alpha Asymmetry to Pediatric Emergence Delirium
This study aimed to investigate whether the association between the preoperative anxiety level and emergence delirium involves EEG frontal alpha asymmetry in pediatric patients undergoing ophthalmic surgery under general anesthesia. The investigators hypothesized that EEG frontal alpha asymmetry contributes a significant portion of the preoperative anxiety - emergence delirium association in pediatric patients. Mediation analysis will be performed to estimate the relationships between preoperative anxiety of children (modified Yale Preoperative Anxiety Scale (mYPAS)), EEG frontal alpha asymmetry, and emergence delirium (Pediatric Assessment of Emergence Delirium (PAED) scale).
- Conditions
- Emergence Delirium
- Being tested
- Ophthalmic surgery, General anesthesia
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic surgeryProcedure or surgery
Ophthalmic surgery will be performed as standard practice of our institution.
General anesthesiaProcedure or surgery
General anesthesia will be performed as standard practice of our institution.
| Study group | Role | What they receive |
|---|---|---|
| Children with emergence delirium | Pediatric patients who develop emergence delirium in the post-anesthetic care unit (PACU).
Emergence delirium will be assessed using the Pediatric Assessment of Emergence Delirium (PAED) scale every 10 min until PACU discharge. Receives: Procedure: Ophthalmic surgery; Procedure: General anesthesia | |
| Children without emergence delirium | Pediatric patients who do not develop emergence delirium in the post-anesthetic care unit (PACU).
Emergence delirium will be assessed using the Pediatric Assessment of Emergence Delirium (PAED) scale every 10 min until PACU discharge. Receives: Procedure: Ophthalmic surgery; Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak PAED score
The peak PAED score is the primary outcome variable for mediation analysis
Measured: After the completion of surgery, during the PACU stay. PAED score will be measured every 10 minutes during the PACU stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start6 Apr 2023
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Song, Gangnam Severance Hospital
- Investigators
- Young Song, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800639
- Sponsor's protocol ID
- 3-2023-0014
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediation Role of Perioperative Electroencephalogram Frontal Alpha Asymmetry to Pediatric Emergence Delirium
- ClinicalTrials.gov ID
- NCT05800639
- Acronym / sponsor ID
- 3-2023-0014
- Conditions
- Emergence Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Apr 2023 (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.
This study aimed to investigate whether the association between the preoperative anxiety level and emergence delirium involves EEG frontal alpha asymmetry in pediatric patients undergoing ophthalmic surgery under general anesthesia. The investigators hypothesized that EEG frontal alpha asymmetry contributes a significant portion of the preoperative anxiety - emergence delirium association in pediatric patients. Mediation analysis will be performed to estimate the relationships between preoperative anxiety of children (modified Yale Preoperative Anxiety Scale (mYPAS)), EEG frontal alpha asymmetry, and emergence delirium (Pediatric Assessment of Emergence Delirium (PAED) scale).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with emergence delirium | – | Procedure: Ophthalmic surgery, Procedure: General anesthesiaPediatric patients who develop emergence delirium in the post-anesthetic care unit (PACU). Emergence delirium will be assessed using the Pediatric Assessment of Emergence Delirium (PAED) scale every 10 min until PACU discharge. |
| Children without emergence delirium | – | Procedure: Ophthalmic surgery, Procedure: General anesthesiaPediatric patients who do not develop emergence delirium in the post-anesthetic care unit (PACU). Emergence delirium will be assessed using the Pediatric Assessment of Emergence Delirium (PAED) scale every 10 min until PACU discharge. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 2-8 year with an American Society of Anesthesiologists (ASA) physical status of I-II who are undergoing elective ophthalmological requiring general anesthesia in Gangnam Severance Hospital will be eligible.
Key inclusion criteria (3 listed)
- Children aged 2-8 year
- Children with an American Society of Anesthesiologists (ASA) physical status of I-II
- Children who are scheduled to undergo elective ophthalmological requiring general anesthesia
Key exclusion criteria (6 listed)
- Emergency surgery
- Patients with developmental delays
- Patients with neurological or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances
- Patients with autism
- Patients with a recent history (within one month) of receiving general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmic surgeryOphthalmic surgery will be performed as standard practice of our institution. | Procedure or surgery | Children with emergence delirium, Children without emergence delirium |
| General anesthesiaGeneral anesthesia will be performed as standard practice of our institution. | Procedure or surgery | Children with emergence delirium, Children without emergence delirium |
Primary outcome
The peak PAED score
Time frame: After the completion of surgery, during the PACU stay. PAED score will be measured every 10 minutes during the PACU stay.
The peak PAED score is the primary outcome variable for mediation analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
Young Song principal investigator
Gangnam Severance Hospital
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 Emergence Delirium, run by Gangnam Severance Hospital 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun-Kyung Park (821024505924, mayskpark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The peak PAED score (time frame: After the completion of surgery, during the PACU stay. PAED score will be measured every 10 minutes during the PACU stay.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.