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OpenTrials
Completed

NCT Number: NCT05701748

EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

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.

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Key information

Age range

3 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients undergoing emergency surgery.
  • Known severe neurological disease which might result in abnormal EEG SEF.
  • Deformities of forehead (difficult EEG sensor placement).
  • Known difficult airway.
  • Allergy to propofol.
  • Attending anesthesiologist on record caring for patient plans to administer additional IV medication besides propofol during study phase.
  • Currently on anti-seizure medication (might alter propofol pharmacodynamics).

Treatment and study plan

Stimuli

Other

placement of oral pacifier, electrical stimulation, and laryngoscopy

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Correlation of propofol blood concentration with EEG SEF95

    Time frame: Once SEF95 stabilizes for at least one minute

    Blood collection and testing

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 27, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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