Anesthesia and EEG Discontinuity in Infants

June 7, 2023 updated by: Ji-Hyun Lee, Seoul National University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Other
      • Seoul, Other, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG discontinuity
Time Frame: From start of anesthesia to end of anesthesia, Less than 24 hours
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
Time Frame: From start of anesthesia to end of study, Less than 24 hours
Total sum of duration of EEG discontinuity
From start of anesthesia to end of study, Less than 24 hours
Significant isoelectric EEG
Time Frame: 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)
From start of anesthesia to end of study, Less than 24 hours
EtSev
Time Frame: From start of anesthesia to end of study, Less than 24 hours
Mean end-tidal sevoflurane concentration during anesthesia
From start of anesthesia to end of study, Less than 24 hours
SEF
Time Frame: From start of anesthesia to end of study, Less than 24 hours
Mean spectral edge frequency value during anesthesia
From start of anesthesia to end of study, Less than 24 hours
PSi
Time Frame: From start of anesthesia to end of study, Less than 24 hours
Mean patient state index value during anesthesia
From start of anesthesia to end of study, Less than 24 hours
Mean blood pressure
Time Frame: From start of anesthesia to end of study, Less than 24 hours
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
Time Frame: From start of anesthesia to end of study, Less than 24 hours
Heart rate values during anesthesia measured every 2.5 minutes
From start of anesthesia to end of study, Less than 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ji-Hyun Lee, M.D., Ph.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2023

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2304-138-1427

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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