Actively Recruiting
Mediation Role of Perioperative Electroencephalogram Frontal Alpha Asymmetry to Pediatric Emergence Delirium
Led by Gangnam Severance Hospital · Updated on 2024-08-15
80
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the link between preoperative anxiety and emergence delirium in children aged 2 to 8 years undergoing eye surgery with general anesthesia. The study focuses on whether brain activity patterns, specifically EEG frontal alpha asymmetry, play a role in this connection. The study will use tools like the modified Yale Preoperative Anxiety Scale and the Pediatric Assessment of Emergence Delirium scale to measure anxiety and delirium levels. The study involves pediatric patients undergoing elective ophthalmic surgery with general anesthesia following standard procedures. Children will be observed in two groups: those who develop emergence delirium and those who do not, based on regular assessments using the PAED scale every 10 minutes until discharge from the post-anesthetic care unit. Participants will be monitored during and after surgery with repeated PAED score assessments to track emergence delirium. Researchers will analyze the relationships between anxiety before surgery, brain activity, and delirium after anesthesia. The main outcome measured is the highest PAED score recorded during the post-anesthetic care unit stay. The study is sponsored by Gangnam Severance Hospital and runs until April 2025.
CONDITIONS
Brief Title
Frontal Alpha Asymmetry and Pediatric Emergence Delirium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 8 years
- Children with an American Society of Anesthesiologists (ASA) physical status of I or II
- Children scheduled for elective ophthalmological surgery requiring general anesthesia
You will not qualify if you...
- Emergency surgery
- Developmental delays
- Neurological or psychiatric diseases associated with agitation, anxiety, attention deficit, or sleep disturbances
- Autism
- Recent general anesthesia within one month
- Congenital or genetic diseases affecting brain development
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and PACU stay
Participants undergo ophthalmic surgery with general anesthesia as part of routine care. Emergence delirium is assessed every 10 minutes during the stay in the post-anesthetic care unit (PACU).
Continuous assessments in PACU until discharge
Duration - Until discharge from PACU
Participants are observed for recovery and any emergence delirium symptoms following surgery and anesthesia.
Monitoring assessments every 10 minutes during PACU stay
Trial Site Locations
Total: 1 location
1
Gangnam Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Sun-Kyung Park
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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