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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores improved methods for monitoring anesthesia depth in young children using EEG, a non-invasive brain activity test. The researchers aim to identify the EEG readings and propofol levels that correspond with a lack of response to specific stimuli during surgery. Eligible participants are children between 3 and 24 months old undergoing surgery with propofol anesthesia, without the need for muscle relaxants.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance anesthesia safety for young children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anti-seizure medication, you cannot participate.

What prior data suggests that EEG monitoring for anesthetic depth is safe for children?

Research shows that using EEG, a test that measures brain activity, to monitor children under propofol anesthesia can be beneficial. Studies have found that EEG monitoring helps adjust the anesthesia dose, allowing children to receive less anesthesia, which could lower risks and side effects.

In past studies, children handled EEG monitoring well. Evidence suggests this method helps maintain the right level of anesthesia, enhancing safety for the child. By keeping anesthesia levels optimal, it may prevent unnecessary exposure to higher doses of anesthetic drugs.

Overall, while every medical procedure carries some risk, current research indicates that using EEG to monitor anesthesia in children is safe and potentially helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using EEG to monitor anesthetic depth in children because it offers a more precise way to assess how deeply a child is sedated when using propofol. Unlike the standard practice of relying mainly on clinical signs and experience, this method uses EEG SEF95 values, which can provide real-time, objective data on brain activity in response to stimuli. This approach could help tailor anesthesia more accurately for children of different ages, improving safety and effectiveness during procedures.

What evidence suggests that EEG monitoring is effective for assessing anesthetic depth in children?

Research shows that EEG, a tool that measures brain activity, helps check how deeply children are under anesthesia during surgery. In this trial, EEG monitoring will assess the depth of anesthesia in response to stimuli. Studies have found that EEG helps doctors adjust the amount of anesthesia needed, leading to better surgery outcomes. For instance, EEG monitoring reveals changes in brain activity that indicate how deeply a child is asleep. This information helps doctors decide whether to give more or less anesthesia. Overall, EEG monitoring makes anesthesia safer and more effective for children by providing real-time information about their brain activity. ^{2 3 4 6 7}

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

Deformities of forehead (difficult EEG sensor placement)

Known difficult airway

Allergy to propofol

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05701748?cond=spectrum&viewType=Table&checkSpell=&rank=2

EEG to Monitor Propofol Anesthetic Depth in Infants and ... The goal of this study is monitor anesthetic depth of children undergoing propofol anesthesia using electroencephalography (EEG). The main questions it aims ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11150110/

Intraoperative pediatric electroencephalography monitoring Recent studies have demonstrated that EEG monitoring may improve periprocedural outcomes in children undergoing anesthesia. Reducing anesthetic dosage.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1566864/full

Propofol-induced frontal aEEG changes in children during ... In older infants and children, EEG monitoring during anesthesia showed that amplitudes were higher during deeper anesthesia stages as measured ...

4. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/9900/age_dependent_entropic_features_during_propofol.1365.aspx

Age-Dependent Entropic Features During Propofol ... We prospectively studied frontal electroencephalogram (EEG) recordings from subjects aged 1 to 18 years receiving propofol anesthesia.

5. ekja.org ekja.org/upload/pdf/kja-23843.pdf

Intraoperative pediatric electroencephalography monitoring Recent studies have demonstrated that EEG monitoring may improve periprocedural outcomes in children undergoing anesthesia. Reducing anesthetic ...

6. journals.lww.com journals.lww.com/10.1097/ALN.0000000000005043

Electroencephalographic Indices for Clinical Endpoints... Propofol Concentration and EEG Parameters​​ They found that BIS value of 50, an “ideal” anesthetic depth during the maintenance phase, corresponded to a propofol ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352556823001509

Electroencephalographic density spectral array monitoring ... DSA monitoring resulted in low-dose application of propofol/sevoflurane preventing the child from unnecessary exposure to anesthetic drugs. Speaking from our ...