Frontal Alpha Asymmetry and Pediatric Emergence Delirium

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05800639

Collaborator

(none)

Enrollment

24.7

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Emergence Delirium	Procedure: Ophthalmic surgery Procedure: General anesthesia

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Mar 30, 2025

Anticipated Study Completion Date :

Apr 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Children with emergence delirium 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.	Procedure: Ophthalmic surgery Ophthalmic surgery will be performed as standard practice of our institution. Procedure: General anesthesia General anesthesia will be performed as standard practice of our institution.
Children without emergence delirium 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.	Procedure: Ophthalmic surgery Ophthalmic surgery will be performed as standard practice of our institution. Procedure: General anesthesia General anesthesia will be performed as standard practice of our institution.

Arm

Intervention/Treatment

Children with emergence delirium

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.

Procedure: Ophthalmic surgery

Ophthalmic surgery will be performed as standard practice of our institution.

Procedure: General anesthesia

General anesthesia will be performed as standard practice of our institution.

Children without emergence delirium

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.

Procedure: Ophthalmic surgery

Ophthalmic surgery will be performed as standard practice of our institution.

Procedure: General anesthesia

General anesthesia will be performed as standard practice of our institution.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 8 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Young Song, Professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT05800639

Other Study ID Numbers:

3-2023-0014

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Emergence Delirium

Anesthetics

Study Results

No Results Posted as of Apr 7, 2023