EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 2
Healthy Volunteers: t
View:

• Children 3 to 24 month old undergoing surgery.

• Planned laryngoscopy and endotracheal intubation or laryngeal mask airway (LMA) placement 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 or LMA.

• Anticipated surgery duration approximately \< 2h40min

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Time Frame
Start Date: 2023-02-03
Completion Date: 2025-01-01
Participants
Target number of participants: 100
Treatments
Experimental: EEG SEF95 values in response to 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.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia

This content was sourced from clinicaltrials.gov