EEG Monitoring for Anesthetic Depth in Children

Overseen By Paula Hu, RN, MSPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Anti-seizure

Disqualifiers: Emergency surgery, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Single session

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Ian Yuan, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children aged 3 to 24 months who need surgery with planned laryngoscopy and propofol anesthesia. They should be generally healthy (ASA < III) without muscle relaxants needed for intubation, not on anti-seizure meds, no known difficult airway or severe neurological issues affecting EEG readings, no allergy to propofol, and have a surgery duration less than approximately 2 hours and 40 minutes.

Inclusion Criteria

My child is between 3 to 24 months old and is having surgery.

I will be given propofol for keeping me asleep during surgery.

I am scheduled for a throat examination and to be put on a breathing tube.

Exclusion Criteria

I am having emergency surgery.

Deformities of forehead (difficult EEG sensor placement)

I have a severe neurological condition that could affect my brain wave tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EEG monitoring and stimuli application to assess anesthetic depth during propofol anesthesia

Single session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EEG to Monitor Propofol Anesthetic Depth
• Stimuli

Trial Overview The study tests how well EEG can monitor the depth of anesthesia in infants/toddlers given propofol during surgery. It looks at the EEG spectral edge frequency where half of patients don't react to stimuli like pacifier placement or electrical stimulation while correlating it with blood levels of propofol.

How Is the Trial Designed?

Group I: EEG SEF95 values in response to stimuli Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+