An interventional study of Stimuli in Electroencephalography Spectral Edge Frequency and Anesthetic Depth, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 3 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
The goal of this study is monitor anesthetic depth of children undergoing propofol anesthesia using electroencephalography (EEG). The main questions it aims to answer are:
Sevoflurane inhalation and propofol intravenous anesthesia are the mainstays of delivering general anesthesia in children. Propofol anesthesia in children is gaining popularity due to fewer respiratory complications, less post-operative nausea vomiting and emergence delirium, compared to sevoflurane. However, unlike sevoflurane, the pharmacodynamics of propofol is less studied in infants and toddlers, particularly the biomarker for propofol brain effect site concentration (Ce), indicative of anesthetic depth. The lack of a real-time biomarker often results in over- or under-dosing of propofol in clinical practice. The goal of this study is to utilize electroencephalography (EEG) as the biomarker of propofol effect site concentration and clinical anesthetic depth, thereby improving the safety and efficacy of propofol anesthesia in this population. In infants and toddlers receiving propofol anesthesia, EEG will be recorded while the patient undergoes three stimuli used to assess anesthetic depth (placement of oral pacifier, electrical stimulation, and laryngoscopy). The EEG index (spectral edge frequency-SEF95) where 50% of patients (ED50) do not respond to each of the three stimuli will be determined as the biomarker of propofol clinical anesthetic depth. In the same cohort, the regression between EEG SEF95 and plasma propofol levels will be determined to assess relationship between EEG SEF95 and propofol Ce.
Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EEG SEF95 values that correspond to the three stimuli being applied, separately enrolled and analyzed for the 3-12mo and 13-24 age groups.
Other: Stimuli
placement of oral pacifier, electrical stimulation, and laryngoscopy
EEG SEF95 value where 50% of infants do not respond to placement of oral pacifier
Observation in OR and EEG data analysis
Time frame: Once SEF95 stabilizes at oral pacifier target SEF95 +/- 1Hz for at least one minute
EEG SEF95 value where 50% of infants do not respond to electrical stimulation
Observation in OR and EEG data analysis
Time frame: Once SEF95 stabilizes at electrical stimulation target SEF95 +/- 1Hz for at least one minute
EEG SEF95 value where 50% of infants do not respond to laryngoscopy
Observation in OR and EEG data analysis
Time frame: Once SEF95 stabilizes at laryngoscopy target SEF95 +/- 1Hz for at least one minute
Correlation of propofol blood concentration with EEG SEF95
Blood collection and testing
Time frame: Once SEF95 stabilizes for at least one minute
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia