Frontal Alpha Asymmetry and Pediatric Emergence Delirium

NCT ID: NCT05800639

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-06

Study Completion Date

2025-04-20

Brief Summary

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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).

Detailed Description

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Conditions

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Emergence Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ophthalmic surgery

Intervention Type PROCEDURE

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

General anesthesia

Intervention Type PROCEDURE

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

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.

Ophthalmic surgery

Intervention Type PROCEDURE

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

General anesthesia

Intervention Type PROCEDURE

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

Interventions

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Ophthalmic surgery

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

Intervention Type PROCEDURE

General anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Song

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Song

Role: PRINCIPAL_INVESTIGATOR

Gangnam Severance Hospital

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sun-Kyung Park

Role: CONTACT

821024505924

Facility Contacts

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Sun-Kyung Park

Role: primary

82-2-2019-4601

Other Identifiers

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3-2023-0014

Identifier Type: -

Identifier Source: org_study_id

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