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Clinical Trials/NCT05800639
NCT05800639
Recruiting
Not Applicable

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

Gangnam Severance Hospital1 site in 1 country80 target enrollmentApril 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergence Delirium
Sponsor
Gangnam Severance Hospital
Enrollment
80
Locations
1
Primary Endpoint
The peak PAED score
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 6, 2023
End Date
April 20, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Song

Professor

Gangnam Severance Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Sites (1)

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