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Frontal Alpha Asymmetry and Pediatric Emergence Delirium

Mediation Role of Perioperative Electroencephalogram Frontal Alpha Asymmetry to Pediatric Emergence Delirium

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05800639
Enrollment
80
Registered
2023-04-05
Start date
2023-04-06
Completion date
2026-12-30
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

Brief 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).

Interventions

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

PROCEDUREGeneral anesthesia

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

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
The peak PAED scoreAfter 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

Countries

South Korea

Contacts

CONTACTSun-Kyung Park
mayskpark@gmail.com821024505924
PRINCIPAL_INVESTIGATORYoung Song

Gangnam Severance Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026