NCT05800639

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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 6, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2025

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

March 24, 2023

Last Update Submit

August 14, 2024

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (1)

  • The peak PAED score

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

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

Study Arms (2)

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 surgeryProcedure: 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 surgeryProcedure: General anesthesia

Interventions

Ophthalmic surgeryPROCEDURE

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

Children with emergence deliriumChildren without emergence delirium
General anesthesiaPROCEDURE

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

Children with emergence deliriumChildren without emergence delirium

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Ophthalmologic Surgical ProceduresAnesthesia, General

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeAnesthesiaAnesthesia and Analgesia

Study Officials

  • Young Song

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun-Kyung Park

CONTACT

821024505924mayskpark@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 5, 2023

Study Start

April 6, 2023

Primary Completion

March 30, 2025

Study Completion

April 20, 2025

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations

KR(1)