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Frontal Alpha Asymmetry and Pediatric Emergence Delirium

Y

Yonsei University Health System (YUHS)

Status

Enrolling

Conditions

Emergence Delirium

Treatments

Procedure: Ophthalmic surgery
Procedure: General anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT05800639
3-2023-0014

Details and patient eligibility

About

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).

Enrollment

80 estimated patients

Sex

All

Ages

2 to 8 years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Children with emergence delirium
Description:
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.
Treatment:
Procedure: General anesthesia
Procedure: Ophthalmic surgery
Children without emergence delirium
Description:
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.
Treatment:
Procedure: General anesthesia
Procedure: Ophthalmic surgery

Trial contacts and locations

1

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Central trial contact

Sun-Kyung Park

Data sourced from clinicaltrials.gov

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