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

Sponsor
Sang-Hwan Ji (Other)
Overall Status
Recruiting
CT.gov ID
NCT05148065
Collaborator
(none)
50
1
16.5
3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: BIS
  • Device: PSi

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Analysis of Relationship Between Depth of Anesthesia by Inhalation Anesthetic and Primitive Electroencephalogram in Children Under Two Years of Age: a Prospective Observational Study
Actual Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Frequency analysis [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

Secondary Outcome Measures

  1. Prediction probability [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

  2. Coherence of BIS and PSi [From start of anesthesia to end of anesthesia, less than 24 hours]

    Coherence of BIS and PSi for prediction of state of anesthesia

  3. Emergence delirium and frequency analysis [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Months to 23 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Sang-Hwan Ji

Investigators

  • Principal Investigator: Sang-Hwan Ji, M.D., Ph.D., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sang-Hwan Ji, Clinical assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05148065
Other Study ID Numbers:
  • 2109-164-1260
First Posted:
Dec 8, 2021
Last Update Posted:
May 16, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Sang-Hwan Ji, Clinical assistant professor, Seoul National University Hospital

Study Results

No Results Posted as of May 16, 2022