Frontal Alpha Asymmetry and Pediatric Emergence Delirium

Recruiting

• Conditions: Emergence Delirium
• Interventions: Procedure: Ophthalmic surgery; Procedure: General anesthesia

• Registration Number: NCT05800639
• Lead Sponsor: Gangnam Severance Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-04-05
• Study Start: 2023-04-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-03-30
• Study Completion: 2025-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children without emergence delirium	General anesthesia	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.
Children without emergence delirium	Ophthalmic surgery	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.
Children with emergence delirium	Ophthalmic surgery	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.
Children with emergence delirium	General anesthesia	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.

Primary Outcome Measures

Name	Time	Method
The peak PAED score	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

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of