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NCT Number: NCT05800639

Frontal Alpha Asymmetry and 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).

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Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Sun-Kyung Park

CONTACT

[email protected]

82-2-2019-4601

Young Song

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ophthalmic surgery

Procedure

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

General Anesthesia

Procedure

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sun-Kyung Park

CONTACT

[email protected]

821024505924

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2023
Registry last updated
Jul 6, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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