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Clinical Trials/KCT0009459
KCT0009459
Not yet recruiting
未知

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

Asan Medical Center0 sites80 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Congenital malformations, deformations and chromosomal abnormalities
Sponsor
Asan Medical Center
Enrollment
80
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational Study
Sex
All

Investigators

Eligibility 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

  • \- 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

Outcomes

Primary Outcomes

Not specified

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