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Comparison of electroencephalographic spectrogram between children undergoing staged operation for functional single ventricle and one-stage total repair of non-cyanotic simple congenital heart disease

Comparison of electroencephalographic spectrogram between children undergoing staged operation for functional single ventricle and one-stage total repair of non-cyanotic simple congenital heart disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009459
Enrollment
80
Registered
2024-05-24
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: children aged 4 months to 6 years who are undergoing BCS surgery, Fontan surgery, or complete corrective surgery for simple acyanotic heart defects. In these children, EEG monitoring is conducted using the SedLine® device (Masimo, Irvine, CA, USA), while continuous administration of Midazolam maintains general anesthesia. The study includes those children whose guardians have heard an explanation about the study, consented to participate, and completed a developmental screening questionnaire prior to surgery.

Exclusion criteria

Exclusion criteria: - cerebrovascular diseases or neuropsychiatric disorders - chromosomal abnormalities - where there are other accompanying malformations besides the heart condition - where the infant was born premature, at less than 37 weeks of gestational age - where the data, including EEG and developmental screening tests, are inadequate - Among patients who have undergone complete corrective surgery for simple heart defects, those who have previously received surgery under general anesthesia - Among patients undergoing complete corrective surgery for simple heart defects, those who experience significant hemodynamic changes or symptoms due to the heart defect, or are taking medication

Design outcomes

Primary

MeasureTime frame
EEG spectrogram

Secondary

MeasureTime frame
developmental screening questionnaire for infants and toddlers

Countries

Korea, Republic of

Contacts

Public ContactHwa-Young Jang

Asan Medical Center

janghy315@amc.seoul.kr+82-2-3010-0762

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026