Anesthesia, General, Anesthesia, Inhalation, Electroencephalography, Infant
Conditions
Keywords
Electroencephalography, Infant, General anesthesia, Burst suppression, Sevoflurane
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.
Interventions
PROCEDUREEEG guided anesthesia
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.
PROCEDUREConventional anesthesia
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total duration of EEG discontinuity | From start of anesthesia to end of study, Less than 24 hours | Total sum of duration of EEG discontinuity |
| 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) |
| EtSev | From start of anesthesia to end of study, Less than 24 hours | Mean end-tidal sevoflurane concentration during anesthesia |
| 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 |
| 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 |
| Heart rate | From start of anesthesia to end of study, Less than 24 hours | Heart rate values during anesthesia measured every 2.5 minutes |
Countries
South Korea
Contacts
Primary ContactSang-Hwan Ji, M.D., Ph.D.
Outcome results
None listed