NCT05148065

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
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Sang-Hwan Ji · Academic / Other
• Sex: All
• Age: 4 Months – 23 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, General
• Sevoflurane
• Infant

Interventions

Type	Name	Description
DEVICE	BIS	Bispectral index monitoring
DEVICE	PSi	Patient state index monitoring

Timeline

• Start date: 2021-12-15
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2021-12-08
• Last updated: 2023-06-09

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study