Frequency Analysis of Raw EEG During Sevoflurane Anesthesia in Children Younger Than 2 Years Old

June 7, 2023 updated by: Sang-Hwan Ji

Analysis of Relationship Between Depth of Anesthesia by Inhalation Anesthetic and Primitive Electroencephalogram in Children Under Two Years of Age: a Prospective Observational Study

The purpose of this study is to analyze raw electroencephalogram in infants younger than 2 years old undergoing general anesthesia using sevoflurane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After obtaining an informed consent from one of the parents, patients undergo routine anesthetic induction using sodium thiopental. Bispectral index and patient state index are both monitored simultaneously. Raw electroencephalogram data are transmitted and recorded via a dedicated equipment. Anesthesia is maintained using sevoflurane with end-tidal level of less than 2 minimum alveolar concentration (MAC) adjusted to age. Fentanyl of up to 1 mcg/kg can be administered in case of increased heart rate and mean blood pressure with a degree of 30% of baseline.

During anesthesia, patients' status of sedation is defined as 'maintenance of surgical state of anesthesia (MOSSA)' when the end-tidal concentration of sevoflurane is maintained between 0.7 and 1.3 MAC and mean blood pressure and heart rate is between 80-120% of baseline.

'Emergence' is defined as a 3-minute period in the middle of continuous decrease in end-tidal concentration of sevoflurane in the range of less than 0.7 MAC and finally reaching 0.2 MAC.

Raw electroencephalogram waves are analyzed by distribution of power along frequency bands and compared according to the state of anesthesia or bispectral index / patient state index value.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

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

4 months to 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients aged between 4 months and 2 years planned to undergo surgery under general anesthesia, whose American Society of Anesthesiologists physical status are 1 or 2

Description

Inclusion Criteria:

  • Pediatric patients aged between 4 months and 2 years planned to undergo surgery under general anesthesia
  • American Society of Anesthesiologists physical status 1 or 2

Exclusion Criteria:

  • History of preterm birth (postconceptual age < 32 wks) or history of mechanical ventilation immediately after birth
  • Presence of genetic disease or chromosomal abnormality that can affect brain development
  • Presence of disease in central nervous system
  • History of head trauma or surgery involving head
  • History of hypersensitivity to anesthetic drugs
  • Intubated or sedated state before induction of anesthesia
  • Difficulty in attaching both the bispectral index and patient state index probes to patient's forehead
  • Expected operation time of less than 5 minutes

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency analysis
Time Frame: From start of anesthesia to end of anesthesia, less than 24 hours
Distribution of raw electroencephalogram waves along frequency bands according to state of anesthesia
From start of anesthesia to end of anesthesia, less than 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction probability
Time Frame: From start of anesthesia to end of anesthesia, less than 24 hours
Prediction probability of bispectral index and patient state index for maintenance of surgical state of anesthesia
From start of anesthesia to end of anesthesia, less than 24 hours
Coherence of BIS and PSi
Time Frame: From start of anesthesia to end of anesthesia, less than 24 hours
Coherence of BIS and PSi for prediction of state of anesthesia
From start of anesthesia to end of anesthesia, less than 24 hours
Emergence delirium and frequency analysis
Time Frame: From start of anesthesia to end of anesthesia, less than 24 hours
Relationship of distribution of electroencephalogram along frequency band at the 'emergence' state and appearance of emergence delirium at the postanesthesia care unit
From start of anesthesia to end of anesthesia, less than 24 hours

Collaborators and Investigators

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

Sponsor

Sang-Hwan Ji

Investigators

  • Principal Investigator: Sang-Hwan Ji, 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 (Actual)

December 15, 2021

Primary Completion (Actual)

May 15, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2109-164-1260

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

Yes

product manufactured in and exported from the U.S.

Yes

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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