Clinical trial NCT05906225: Anesthesia and EEG Discontinuity in Infants
Official title: The Impact of Electroencephalogram (EEG) - Guided Inhalational Anesthetic Control on the Occurrence of EEG Discontinuity in Infants: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, General
Electroencephalography
Infant
Anesthesia, Inhalation
Keywords: Electroencephalography
Infant
General anesthesia
Burst suppression
Sevoflurane
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 78
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: EEG discontinuity
timeFrame: From start of anesthesia to end of anesthesia, Less than 24 hours
Secondary outcomes:
measure: Total duration of EEG discontinuity
timeFrame: From start of anesthesia to end of study, Less than 24 hours
measure: Significant isoelectric EEG
timeFrame: From start of anesthesia to end of study, Less than 24 hours
measure: EtSev
timeFrame: From start of anesthesia to end of study, Less than 24 hours
measure: SEF
timeFrame: From start of anesthesia to end of study, Less than 24 hours
measure: PSi
timeFrame: From start of anesthesia to end of study, Less than 24 hours
measure: Mean blood pressure
timeFrame: From start of anesthesia to end of study, Less than 24 hours
measure: Heart rate
timeFrame: From start of anesthesia to end of study, Less than 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Other
Study officials:
affiliation: Seoul National University Hospital
name: Ji-Hyun Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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