Back to resultsAnesthesia and EEG Discontinuity in Infants
Primary Purpose
Anesthesia, General, Electroencephalography, Infant
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EEG guided anesthesia
Conventional anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia, General focused on measuring Electroencephalography, Infant, General anesthesia, Burst suppression, Sevoflurane
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electroencephalogram
Conventional
Arm Description
Adjustment of concentration of sevoflurane according to EEG
Adjustment of concentration of sevoflurane according to vital signs
Outcomes
Primary Outcome Measures
EEG discontinuity
Incidence of EEG discontinuity (EEG amplitudes < 25uV for more than 2 seconds)
Secondary Outcome Measures
Total duration of EEG discontinuity
Total sum of duration of EEG discontinuity
Significant isoelectric EEG
Incidence of significant isoelectric EEG (EEG amplitudes < 10uV for more than 2 seconds)
EtSev
Mean end-tidal sevoflurane concentration during anesthesia
SEF
Mean spectral edge frequency value during anesthesia
PSi
Mean patient state index value during anesthesia
Mean blood pressure
Mean blood pressure values during anesthesia measured every 2.5 minutes
Heart rate
Heart rate values during anesthesia measured every 2.5 minutes
Full Information
NCT ID
NCT05906225
First Posted
June 7, 2023
Last Updated
June 7, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05906225
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, General, Electroencephalography, Infant, Anesthesia, Inhalation
Keywords
Electroencephalography, Infant, General anesthesia, Burst suppression, Sevoflurane
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroencephalogram
Arm Type
Experimental
Arm Description
Adjustment of concentration of sevoflurane according to EEG
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Adjustment of concentration of sevoflurane according to vital signs
Intervention Type
Procedure
Intervention Name(s)
EEG guided anesthesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
EEG discontinuity
Description
Incidence of EEG discontinuity (EEG amplitudes < 25uV for more than 2 seconds)
Time Frame
From start of anesthesia to end of anesthesia, Less than 24 hours
Secondary Outcome Measure Information:
Title
Total duration of EEG discontinuity
Description
Total sum of duration of EEG discontinuity
Time Frame
From start of anesthesia to end of study, Less than 24 hours
Title
Significant isoelectric EEG
Description
Incidence of significant isoelectric EEG (EEG amplitudes < 10uV for more than 2 seconds)
Time Frame
From start of anesthesia to end of study, Less than 24 hours
Title
EtSev
Description
Mean end-tidal sevoflurane concentration during anesthesia
Time Frame
From start of anesthesia to end of study, Less than 24 hours
Title
SEF
Description
Mean spectral edge frequency value during anesthesia
Time Frame
From start of anesthesia to end of study, Less than 24 hours
Title
PSi
Description
Mean patient state index value during anesthesia
Time Frame
From start of anesthesia to end of study, Less than 24 hours
Title
Mean blood pressure
Description
Mean blood pressure values during anesthesia measured every 2.5 minutes
Time Frame
From start of anesthesia to end of study, Less than 24 hours
Title
Heart rate
Description
Heart rate values during anesthesia measured every 2.5 minutes
Time Frame
From start of anesthesia to end of study, Less than 24 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang-Hwan Ji, M.D., Ph.D.
Phone
+82-2-2072-3661
Email
taepoongshin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Hyun Lee, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Other
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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26102526
Citation
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Anesthesia and EEG Discontinuity in Infants
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