EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

January 28, 2025 updated by: Children's Hospital of Philadelphia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Stimuli
placement of oral pacifier, electrical stimulation, and laryngoscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of propofol blood concentration with EEG SEF95
Time Frame: Once SEF95 stabilizes for at least one minute
Blood collection and testing
Once SEF95 stabilizes for at least one minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Ian Yuan, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 22-019941

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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