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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05148065
Enrollment
50
Registered
2021-12-08
Start date
2021-12-15
Completion date
2023-05-15
Last updated
2023-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General, Sevoflurane, Infant

Keywords

Electroenphalography, Frequency analysis

Brief summary

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

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.

Interventions

DEVICEBIS

Bispectral index monitoring

DEVICEPSi

Patient state index monitoring

Sponsors

Sang-Hwan Ji
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Months to 23 Months
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

Design outcomes

Primary

MeasureTime frameDescription
Frequency analysisFrom start of anesthesia to end of anesthesia, less than 24 hoursDistribution of raw electroencephalogram waves along frequency bands according to state of anesthesia

Secondary

MeasureTime frameDescription
Prediction probabilityFrom start of anesthesia to end of anesthesia, less than 24 hoursPrediction probability of bispectral index and patient state index for maintenance of surgical state of anesthesia
Coherence of BIS and PSiFrom start of anesthesia to end of anesthesia, less than 24 hoursCoherence of BIS and PSi for prediction of state of anesthesia
Emergence delirium and frequency analysisFrom start of anesthesia to end of anesthesia, less than 24 hoursRelationship of distribution of electroencephalogram along frequency band at the 'emergence' state and appearance of emergence delirium at the postanesthesia care unit

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026