Anesthesia and EEG Discontinuity in Infants

Not Applicable

Not yet recruiting

• Conditions: Anesthesia, General; Electroencephalography; Infant; Anesthesia, Inhalation
• Interventions: Procedure: Conventional anesthesia; Procedure: EEG guided anesthesia

• Registration Number: NCT05906225
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study is a randomized controlled trial to evaluate whether EEG-guided calibration of inhalation agents can reduce occurrence of EEG discontinuity in infants during general anesthesia.

Detailed Description

This is a study for comparison of incidence of EEG discontinuity during general anesthesia using sevoflurane. EEG guidance group will receive calibration of fraction of inhalational sevoflurane according to components of slow wave and delta wave of raw EEG. Control group will receive conventional management of anesthesia according to vital signs.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Study Start: 2023-06-20
• Primary Completion: 2025-03-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Infants who were born as full-term (>37 weeks postconception) and are equal to or less than 12 month old who were scheduled to undergo surgery under general anesthesia using inhalation agents.
• Belongs to American Society of Anesthesiologists Physical Status 1 or 2

Exclusion Criteria

• Infants who were born less than 37 weeks postconception or has history of mechanical ventilation immediately after birth
• Presence of any genetic disease, chromosomal anomaly or congenital anomaly that can affect brain development
• Presence of any disease or disability in central nervous system
• History of trauma at head or surgery on brain
• History of hypersensitivity to any anesthetic agents
• Status of sedation or endotracheal intubation before induction of anesthesia
• Inability to attach probes for EEG monitoring
• Expectation of operation time as less than 5 minutes
• Other conditions that researchers regard as inappropriate for enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional anesthesia	Adjustment of concentration of sevoflurane according to vital signs
Electroencephalogram	EEG guided anesthesia	Adjustment of concentration of sevoflurane according to EEG

Primary Outcome Measures

Name	Time	Method
EEG discontinuity	From start of anesthesia to end of anesthesia, Less than 24 hours	Incidence of EEG discontinuity (EEG amplitudes \< 25uV for more than 2 seconds)

Secondary Outcome Measures

Name	Time	Method
SEF	From start of anesthesia to end of study, Less than 24 hours	Mean spectral edge frequency value during anesthesia
PSi	From start of anesthesia to end of study, Less than 24 hours	Mean patient state index value during anesthesia
Heart rate	From start of anesthesia to end of study, Less than 24 hours	Heart rate values during anesthesia measured every 2.5 minutes
Total duration of EEG discontinuity	From start of anesthesia to end of study, Less than 24 hours	Total sum of duration of EEG discontinuity
EtSev	From start of anesthesia to end of study, Less than 24 hours	Mean end-tidal sevoflurane concentration during anesthesia
Significant isoelectric EEG	From start of anesthesia to end of study, Less than 24 hours	Incidence of significant isoelectric EEG (EEG amplitudes \< 10uV for more than 2 seconds)
Mean blood pressure	From start of anesthesia to end of study, Less than 24 hours	Mean blood pressure values during anesthesia measured every 2.5 minutes

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Other, Korea, Republic of