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RecruitingNCT05800639Updated Jul 6, 2026

Frontal Alpha Asymmetry and Pediatric Emergence Delirium

An observational study in Emergence Delirium, sponsored by Gangnam Severance Hospital. Recruiting at 1 site in South Korea. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Gangnam Severance Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
2 Years to 8 Years
Sex
All
01

Study 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. 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).

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Conditions studied

  • Emergence Delirium

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03

Who can participate

Ages eligible
2 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Procedure: Ophthalmic surgery · Procedure: General anesthesia

Interventions

  • ProcedureOphthalmic surgery

    Ophthalmic surgery will be performed as standard practice of our institution.

  • ProcedureGeneral anesthesia

    General anesthesia will be performed as standard practice of our institution.

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What researchers measure

Primary outcomes

  1. The peak PAED score

    The peak PAED score is the primary outcome variable for mediation analysis

    Time frame: After the completion of surgery, during the PACU stay. PAED score will be measured every 10 minutes during the PACU stay.

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Study locations

1 of 1 sites recruiting
  • Gangnam Severance Hospital
    Seoul, South Korea
    • Sun-Kyung Park · Contact · mayskpark@gmail.com · 82-2-2019-4601
    • Young Song · Principal investigator
    Recruiting
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Registry details

Key details

Study ID
NCT05800639
Lead sponsor
Gangnam Severance Hospital
Responsible party
Young Song (Professor, Gangnam Severance Hospital) — Principal investigator
First posted
Apr 5, 2023
Start date
Apr 6, 2023
Primary completion
Dec 20, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jul 6, 2026

Study contacts

Sun-Kyung Park
Contact
mayskpark@gmail.com
821024505924
Young Song
principal investigator · Gangnam Severance Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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