Anesthesia and EEG Discontinuity in Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Electroencephalogram (EEG) - Guided Inhalational Anesthetic Control on the Occurrence of EEG Discontinuity in Infants: A Prospective Randomized Controlled Trial

Conditions
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Anesthesia, General, Electroencephalography, Infant, Anesthesia, Inhalation

Intervention / Treatment
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* Procedure: EEG guided anesthesia
* Procedure: Conventional anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroencephalogram<br>Adjustment of concentration of sevoflurane according to EEG | Procedure: EEG guided anesthesia<br>* Monitoring of electroencephalogram via Sedline probe by MASIMO corporation. Adjust concentration of inhalational sevoflurane during anesthesia, according to component of slow&delta wave and alpha wave, so that slow/delta oscillation (with or without alpha oscillation) is maintained.<br>|
| Active Comparator: Conventional<br>Adjustment of concentration of sevoflurane according to vital signs | Procedure: Conventional anesthesia<br>* Adjust concentration of inhalational sevoflurane during anesthesia, according to vital signs, so that mean blood pressure and heart rate are maintained between 80% and 120% of baseline values measured at ward before anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG discontinuity | Incidence of EEG discontinuity (EEG amplitudes < 25uV for more than 2 seconds) | From start of anesthesia to end of anesthesia, Less than 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroencephalography, Infant, General anesthesia, Burst suppression, Sevoflurane