Anesthesia and EEG Discontinuity in Infants

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05906225

Collaborator

(none)

Enrollment

Location

Arms

23.3

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, General Electroencephalography Infant Anesthesia, Inhalation	Procedure: EEG guided anesthesia Procedure: Conventional anesthesia	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 20, 2023

Anticipated Primary Completion Date :

Mar 30, 2025

Anticipated Study Completion Date :

May 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electroencephalogram Adjustment of concentration of sevoflurane according to EEG	Procedure: EEG 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.
Active Comparator: Conventional Adjustment of concentration of sevoflurane according to vital signs	Procedure: Conventional 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.

Arm

Intervention/Treatment

Experimental: Electroencephalogram

Adjustment of concentration of sevoflurane according to EEG

Procedure: EEG 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.

Active Comparator: Conventional

Adjustment of concentration of sevoflurane according to vital signs

Procedure: Conventional 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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