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Electroencephalography Spectral Edge FrequencyNCT05701748

EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

A study testing Stimuli in people with Electroencephalography Spectral Edge Frequency and Anesthetic Depth, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 24 monthsHealthy volunteers can take part
What is being tested?
Stimuli
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
3 Feb 2023to 1 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.
Read the 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.

Being tested
Stimuli

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StimuliOther

    placement of oral pacifier, electrical stimulation, and laryngoscopy

Study groups in NCT05701748
Study groupRoleWhat they receive
EEG SEF95 values in response to stimuliExperimentalEEG SEF95 values that correspond to the three stimuli being applied, separately enrolled and analyzed for the 3-12mo and 13-24 age groups.
Receives: Other: Stimuli

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG SEF95 value where 50% of infants do not respond to placement of oral pacifier

    Observation in OR and EEG data analysis

    Measured: Once SEF95 stabilizes at oral pacifier target SEF95 +/- 1Hz for at least one minute

  2. EEG SEF95 value where 50% of infants do not respond to electrical stimulation

    Observation in OR and EEG data analysis

    Measured: Once SEF95 stabilizes at electrical stimulation target SEF95 +/- 1Hz for at least one minute

  3. EEG SEF95 value where 50% of infants do not respond to laryngoscopy

    Observation in OR and EEG data analysis

    Measured: Once SEF95 stabilizes at laryngoscopy target SEF95 +/- 1Hz for at least one minute

Secondary outcomes (1)

  1. Correlation of propofol blood concentration with EEG SEF95

    Blood collection and testing

    Measured: Once SEF95 stabilizes for at least one minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start3 Feb 2023
  3. Primary completion31 Dec 2024
  4. Study completion1 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701748
Sponsor's protocol ID
22-019941
Status last verified
Jan 2025
First submitted
17 Jan 2023
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Brioni JD, Varughese S, Ahmed R, Bein B. A clinical review of inhalation anesthesia with sevoflurane: from early research to emerging topics. J Anesth. 2017 Oct;31(5):764-778. doi: 10.1007/s00540-017-2375-6. Epub 2017 Jun 5.

    PubMed 28585095

  • Chidambaran V, Costandi A, D'Mello A. Propofol: a review of its role in pediatric anesthesia and sedation. CNS Drugs. 2015 Jul;29(7):543-63. doi: 10.1007/s40263-015-0259-6.

    PubMed 26290263

  • Morse J, Hannam JA, Cortinez LI, Allegaert K, Anderson BJ. A manual propofol infusion regimen for neonates and infants. Paediatr Anaesth. 2019 Sep;29(9):907-914. doi: 10.1111/pan.13706. Epub 2019 Aug 12.

    PubMed 31325395

  • Sepulveda P, Cortinez LI, Saez C, Penna A, Solari S, Guerra I, Absalom AR. Performance evaluation of paediatric propofol pharmacokinetic models in healthy young children. Br J Anaesth. 2011 Oct;107(4):593-600. doi: 10.1093/bja/aer198. Epub 2011 Jul 9.

    PubMed 21743068

  • Oberer C, von Ungern-Sternberg BS, Frei FJ, Erb TO. Respiratory reflex responses of the larynx differ between sevoflurane and propofol in pediatric patients. Anesthesiology. 2005 Dec;103(6):1142-8. doi: 10.1097/00000542-200512000-00007.

    PubMed 16306725

  • Chandler JR, Myers D, Mehta D, Whyte E, Groberman MK, Montgomery CJ, Ansermino JM. Emergence delirium in children: a randomized trial to compare total intravenous anesthesia with propofol and remifentanil to inhalational sevoflurane anesthesia. Paediatr Anaesth. 2013 Apr;23(4):309-15. doi: 10.1111/pan.12090.

    PubMed 23464658

  • Sneyd JR, Carr A, Byrom WD, Bilski AJ. A meta-analysis of nausea and vomiting following maintenance of anaesthesia with propofol or inhalational agents. Eur J Anaesthesiol. 1998 Jul;15(4):433-45. doi: 10.1046/j.1365-2346.1998.00319.x.

    PubMed 9699101

  • Sarner JB, Levine M, Davis PJ, Lerman J, Cook DR, Motoyama EK. Clinical characteristics of sevoflurane in children. A comparison with halothane. Anesthesiology. 1995 Jan;82(1):38-46. doi: 10.1097/00000542-199501000-00006.

    PubMed 7832332

  • Lerman J, Sikich N, Kleinman S, Yentis S. The pharmacology of sevoflurane in infants and children. Anesthesiology. 1994 Apr;80(4):814-24. doi: 10.1097/00000542-199404000-00014.

    PubMed 8024136

  • Kim TK, Niklewski PJ, Martin JF, Obara S, Egan TD. Enhancing a sedation score to include truly noxious stimulation: the Extended Observer's Assessment of Alertness and Sedation (EOAA/S). Br J Anaesth. 2015 Oct;115(4):569-77. doi: 10.1093/bja/aev306.

    PubMed 26385665

  • Fuentes R, Cortinez I, Ibacache M, Concha M, Munoz H. Propofol concentration to induce general anesthesia in children aged 3-11 years with the Kataria effect-site model. Paediatr Anaesth. 2015 Jun;25(6):554-9. doi: 10.1111/pan.12657. Epub 2015 Apr 16.

    PubMed 25880448

  • Xu T, Kurth CD, Yuan I, Vutskits L, Zhu T. An approach to using pharmacokinetics and electroencephalography for propofol anesthesia for surgery in infants. Paediatr Anaesth. 2020 Dec;30(12):1299-1307. doi: 10.1111/pan.14021. Epub 2020 Oct 28.

    PubMed 32965066

  • Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.

    PubMed 26275092

  • Chan MTV, Hedrick TL, Egan TD, Garcia PS, Koch S, Purdon PL, Ramsay MA, Miller TE, McEvoy MD, Gan TJ; Perioperative Quality Initiative (POQI) 6 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on the Role of Neuromonitoring in Perioperative Outcomes: Electroencephalography. Anesth Analg. 2020 May;130(5):1278-1291. doi: 10.1213/ANE.0000000000004502.

    PubMed 31764163

  • Yuan I, Xu T, Skowno J, Zhang B, Davidson A, von Ungern-Sternberg BS, Sommerfield D, Zhang J, Song X, Zhang M, Zhao P, Liu H, Jiang Y, Zuo Y, de Graaff JC, Vutskits L, Olbrecht VA, Szmuk P, Kurth CD; BRAIN Collaborative Investigators. Isoelectric Electroencephalography in Infants and Toddlers during Anesthesia for Surgery: An International Observational Study. Anesthesiology. 2022 Aug 1;137(2):187-200. doi: 10.1097/ALN.0000000000004262.

    PubMed 35503999

Questions about this trial

What is this clinical trial studying?

A study testing Stimuli in people with Electroencephalography Spectral Edge Frequency and Anesthetic Depth, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701748, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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