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Completed

NCT Number: NCT05148065

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

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

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Key information

Age range

4 month–23 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS

Device

Bispectral index monitoring

PSI

Device

Patient state index monitoring

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Sang-Hwan Ji

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2021
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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