EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

Study Overview
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Brief Summary
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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: EEG spectral edge frequency (SEF) readings where 50% of patients do not respond to three stimuli. The propofol blood concentration that corresponds to each of the three EEG SEF readings Participants will undergo EEG monitoring, stimuli (placement of oral pacifier, electrical stimulation, and laryngoscopy), and blood collection.

Detailed Description
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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-SEF) where 50% of patients 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 SEF and plasma propofol levels will be determined to assess relationship between EEG SEF and propofol Ce.

Official Title
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EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

Conditions
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Electroencephalography Spectral Edge Frequency, Anesthetic Depth

Intervention / Treatment
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* Other: Stimuli


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 3 to 24 month old undergoing surgery. Planned laryngoscopy and endotracheal intubation for clinical care. Planned propofol anesthesia for anesthesia maintenance. American Society of Anesthesiologists (ASA ) < III. Muscle relaxant not indicated per planned clinical care for laryngoscopy/intubation. Anticipated surgery duration approximately < 2h40min Exclusion Criteria: Patients undergoing emergency surgery. Known severe neurological disease which might result in abnormal EEG SEF. Deformities of forehead (difficult EEG sensor placement). Known difficult airway. Allergy to propofol. Attending anesthesiologist on record caring for patient plans to administer additional IV medication besides propofol during study phase. Currently on anti-seizure medication (might alter propofol pharmacodynamics).

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG SEF values in response to stimuli<br>EEG SEF values that correspond to the three stimuli being applied | Other: Stimuli<br>* placement of oral pacifier, electrical stimulation, and laryngoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG SEF50 value for placement of oral pacifier | Observation in OR and EEG data analysis | 20 minutes | 
| EEG SEF50 value for electrical stimulation | Observation in OR and EEG data analysis | 20 minutes | 
| EEG SEF50 value for laryngoscopy | Observation in OR and EEG data analysis | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol blood concentration at EEG SEF50 for placement of oral pacifier | Blood collection and testing | 20 minutes | 
| Propofol blood concentration at EEG SEF50 for electrical stimulation | Blood collection and testing | 20 minutes | 
| Propofol blood concentration at EEG SEF50 for laryngoscopy | Blood collection and testing | 20 minutes |