Clinical trial NCT05701748: EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers
Official title: EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electroencephalography Spectral Edge Frequency
Anesthetic Depth
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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:

1. EEG spectral edge frequency (SEF95) readings where 50% of patients do not respond to three stimuli.
2. The propofol blood concentration that corresponds to each of the three EEG SEF95 readings Participants will undergo EEG monitoring, stimuli (placement of oral pacifier, electrical stimulation, and laryngoscopy), and blood collection.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Children 3 to 24 month old undergoing surgery.
2. Planned laryngoscopy and endotracheal intubation or laryngeal mask airway (LMA) placement for clinical care.
3. Planned propofol anesthesia for anesthesia maintenance.
4. American Society of Anesthesiologists (ASA ) \< III.
5. Muscle relaxant not indicated per planned clinical care for laryngoscopy/intubation or LMA.
6. Anticipated surgery duration approximately \< 2h40min

Exclusion Criteria:

1. Patients undergoing emergency surgery.
2. Known severe neurological disease which might result in abnormal EEG SEF.
3. Deformities of forehead (difficult EEG sensor placement).
4. Known difficult airway.
5. Allergy to propofol.
6. Attending anesthesiologist on record caring for patient plans to administer additional IV medication besides propofol during study phase.
7. Currently on anti-seizure medication (might alter propofol pharmacodynamics).

Primary outcomes:
measure: EEG SEF95 value where 50% of infants do not respond to placement of oral pacifier
timeFrame: Once SEF95 stabilizes at oral pacifier target SEF95 +/- 1Hz for at least one minute
measure: EEG SEF95 value where 50% of infants do not respond to electrical stimulation
timeFrame: Once SEF95 stabilizes at electrical stimulation target SEF95 +/- 1Hz for at least one minute
measure: EEG SEF95 value where 50% of infants do not respond to laryngoscopy
timeFrame: Once SEF95 stabilizes at laryngoscopy target SEF95 +/- 1Hz for at least one minute
Secondary outcomes:
measure: Correlation of propofol blood concentration with EEG SEF95
timeFrame: Once SEF95 stabilizes for at least one minute
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Ian Yuan, MD
role: PRINCIPAL_INVESTIGATOR
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