EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

Not Applicable

Recruiting

• Conditions: Electroencephalography Spectral Edge Frequency; Anesthetic Depth
• Interventions: Other: Stimuli

• Registration Number: NCT05701748
• Lead Sponsor: Children's Hospital of Philadelphia

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 (SEF) readings where 50% of patients do not respond to three stimuli.

2. 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

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.

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-27
• Study Start: 2023-02-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Children 3 to 24 month old undergoing surgery.
2. Planned laryngoscopy and endotracheal intubation 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.
6. Anticipated surgery duration approximately < 2h40min

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EEG SEF95 values in response to stimuli	Stimuli	EEG SEF95 values that correspond to the three stimuli being applied, separately enrolled and analyzed for the 3-12mo and 13-24 age groups.

Primary Outcome Measures

Name	Time	Method
EEG SEF95 value where 50% of infants do not respond to placement of oral pacifier	Once SEF95 stabilizes at oral pacifier target SEF95 +/- 1Hz for at least one minute	Observation in OR and EEG data analysis
EEG SEF95 value where 50% of infants do not respond to electrical stimulation	Once SEF95 stabilizes at electrical stimulation target SEF95 +/- 1Hz for at least one minute	Observation in OR and EEG data analysis
EEG SEF95 value where 50% of infants do not respond to laryngoscopy	Once SEF95 stabilizes at laryngoscopy target SEF95 +/- 1Hz for at least one minute	Observation in OR and EEG data analysis

Secondary Outcome Measures

Name	Time	Method
Correlation of propofol blood concentration with EEG SEF95	Once SEF95 stabilizes for at least one minute	Blood collection and testing

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States