Investigating the link between preoperative anxiety and emergence delirium in children
Mediation Role of Perioperative Electroencephalogram Frontal Alpha Asymmetry to Pediatric Emergence Delirium
This study is trying to see if kids aged 2-8 who feel anxious before eye surgery are more likely to experience confusion as they wake up from anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 2 Years to 8 Years |
| Sex | All |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05800639 on ClinicalTrials.gov |
What this trial studies
This observational study examines the relationship between preoperative anxiety levels and emergence delirium in pediatric patients undergoing elective ophthalmic surgery under general anesthesia. The researchers hypothesize that EEG frontal alpha asymmetry plays a significant role in this association. They will utilize the modified Yale Preoperative Anxiety Scale (mYPAS) to assess anxiety and the Pediatric Assessment of Emergence Delirium (PAED) scale to evaluate emergence delirium. Mediation analysis will be conducted to explore these relationships in children aged 2-8 years.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-8 years scheduled for elective ophthalmic surgery requiring general anesthesia.
Not a fit: Patients who may not benefit from this study include those undergoing emergency surgery or those with developmental delays or psychiatric conditions.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of emergence delirium in pediatric patients, enhancing their surgical experience.
How similar studies have performed: While the specific approach of examining EEG frontal alpha asymmetry in this context may be novel, studies on emergence delirium and preoperative anxiety have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Gangnam Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Young Song — Gangnam Severance Hospital
- Study coordinator: Sun-Kyung Park
- Email: mayskpark@gmail.com
- Phone: 821024505924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.