EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

NCT05701748 | Completed DMC

• 1 other identifier: 22-019941
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.EEG spectral edge frequency (SEF95) readings where 50% of patients do not respond to three stimuli.
2. 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.

Conditions

Electroencephalography Spectral Edge Frequency; Anesthetic Depth

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  Observation in OR and EEG data analysis

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

Secondary Outcomes (1)

• Correlation of propofol blood concentration with EEG SEF95

  Once SEF95 stabilizes for at least one minute

Study Arms (1)

EEG SEF95 values in response to stimuli

EXPERIMENTAL

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

Interventions

Stimuli OTHER

placement of oral pacifier, electrical stimulation, and laryngoscopy

EEG SEF95 values in response to stimuli

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (33)

• 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.

  PMID: 28585095 BACKGROUND

• 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.

  PMID: 26290263 BACKGROUND

• 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.

  PMID: 31325395 BACKGROUND

• 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.

  PMID: 21743068 BACKGROUND

• 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.

  PMID: 16306725 BACKGROUND

• 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.

  PMID: 23464658 BACKGROUND

• 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.

  PMID: 9699101 BACKGROUND

• 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.

  PMID: 7832332 BACKGROUND

• 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.

  PMID: 8024136 BACKGROUND

• 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.

  PMID: 26385665 BACKGROUND

• 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.

  PMID: 25880448 BACKGROUND

• 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.

  PMID: 32965066 BACKGROUND

• 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.

  PMID: 26275092 BACKGROUND

• 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.

  PMID: 31764163 BACKGROUND

• 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.

  PMID: 35503999 BACKGROUND

• FDA. Propofol FDA https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf. Accessed

  BACKGROUND

• Yuan I, Xu T, Kurth CD. Using Electroencephalography (EEG) to Guide Propofol and Sevoflurane Dosing in Pediatric Anesthesia. Anesthesiol Clin. 2020 Sep;38(3):709-725. doi: 10.1016/j.anclin.2020.06.007.

  PMID: 32792193 BACKGROUND

• Hayashi K, Shigemi K, Sawa T. Neonatal electroencephalography shows low sensitivity to anesthesia. Neurosci Lett. 2012 May 31;517(2):87-91. doi: 10.1016/j.neulet.2012.04.028. Epub 2012 Apr 19.

  PMID: 22542892 BACKGROUND

• Davidson AJ, Wong A, Knottenbelt G, Sheppard S, Donath S, Frawley G. MAC-awake of sevoflurane in children. Paediatr Anaesth. 2008 Aug;18(8):702-7. doi: 10.1111/j.1460-9592.2008.02664.x.

  PMID: 18613929 BACKGROUND

• Zbinden AM, Maggiorini M, Petersen-Felix S, Lauber R, Thomson DA, Minder CE. Anesthetic depth defined using multiple noxious stimuli during isoflurane/oxygen anesthesia. I. Motor reactions. Anesthesiology. 1994 Feb;80(2):253-60. doi: 10.1097/00000542-199402000-00004.

  PMID: 8311307 BACKGROUND

• Inomata S, Kihara S, Yaguchi Y, Baba Y, Kohda Y, Toyooka H. Reduction in standard MAC and MAC for intubation after clonidine premedication in children. Br J Anaesth. 2000 Nov;85(5):700-4. doi: 10.1093/bja/85.5.700.

  PMID: 11094583 BACKGROUND

• Dixon W. The up-and-down method for small samples. Journal of the American Statistical Association. 1965;60(312):967-978.

  BACKGROUND

• Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a precis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. doi: 10.1097/01.anes.0000267514.42592.2a.

  PMID: 17585226 BACKGROUND

• Gorges M, Zhou G, Brant R, Ansermino JM. Sequential allocation trial design in anesthesia: an introduction to methods, modeling, and clinical applications. Paediatr Anaesth. 2017 Mar;27(3):240-247. doi: 10.1111/pan.13088. Epub 2017 Feb 17.

  PMID: 28211193 BACKGROUND

• Kataria BK, Ved SA, Nicodemus HF, Hoy GR, Lea D, Dubois MY, Mandema JW, Shafer SL. The pharmacokinetics of propofol in children using three different data analysis approaches. Anesthesiology. 1994 Jan;80(1):104-22. doi: 10.1097/00000542-199401000-00018.

  PMID: 8291699 BACKGROUND

• Coppens MJ, Eleveld DJ, Proost JH, Marks LA, Van Bocxlaer JF, Vereecke H, Absalom AR, Struys MM. An evaluation of using population pharmacokinetic models to estimate pharmacodynamic parameters for propofol and bispectral index in children. Anesthesiology. 2011 Jul;115(1):83-93. doi: 10.1097/ALN.0b013e31821a8d80.

  PMID: 21555936 BACKGROUND

• Absalom A, Amutike D, Lal A, White M, Kenny GN. Accuracy of the 'Paedfusor' in children undergoing cardiac surgery or catheterization. Br J Anaesth. 2003 Oct;91(4):507-13. doi: 10.1093/bja/aeg220.

  PMID: 14504151 BACKGROUND

• Rigouzzo A, Girault L, Louvet N, Servin F, De-Smet T, Piat V, Seeman R, Murat I, Constant I. The relationship between bispectral index and propofol during target-controlled infusion anesthesia: a comparative study between children and young adults. Anesth Analg. 2008 Apr;106(4):1109-16, table of contents. doi: 10.1213/ane.0b013e318164f388.

  PMID: 18349180 BACKGROUND

• Sahinovic MM, Struys MMRF, Absalom AR. Clinical Pharmacokinetics and Pharmacodynamics of Propofol. Clin Pharmacokinet. 2018 Dec;57(12):1539-1558. doi: 10.1007/s40262-018-0672-3.

  PMID: 30019172 BACKGROUND

• Olbrecht VA, Jiang Y, Viola L, Walter CM, Liu H, Kurth CD. Characterization of the functional near-infrared spectroscopy response to nociception in a pediatric population. Paediatr Anaesth. 2018 Feb;28(2):103-111. doi: 10.1111/pan.13301. Epub 2017 Dec 27.

  PMID: 29280254 BACKGROUND

• Hammer GB, Litalien C, Wellis V, Drover DR. Determination of the median effective concentration (EC50) of propofol during oesophagogastroduodenoscopy in children. Paediatr Anaesth. 2001;11(5):549-53. doi: 10.1046/j.1460-9592.2001.00731.x.

  PMID: 11696118 BACKGROUND

• Yuan I, Landis WP, Topjian AA, Abend NS, Lang SS, Huh JW, Kirschen MP, Mensinger JL, Zhang B, Kurth CD. Prevalence of Isoelectric Electroencephalography Events in Infants and Young Children Undergoing General Anesthesia. Anesth Analg. 2020 Feb;130(2):462-471. doi: 10.1213/ANE.0000000000004221.

  PMID: 31107263 BACKGROUND

• Disma N, Veyckemans F, Virag K, Hansen TG, Becke K, Harlet P, Vutskits L, Walker SM, de Graaff JC, Zielinska M, Simic D, Engelhardt T, Habre W; NECTARINE Group of the European Society of Anaesthesiology Clinical Trial Network; Austria; Belgium; Croatia; Czech Republic; Denmark; Estonia; Finland; France; Germany; Greece; Hungary; Ireland; Italy; Latvia; Lithuania; Luxembourg; Malta; Netherlands; Norway; Poland; Portugal; Romania; Serbia; Slovakia; Slovenia; Spain; Switzerland; Turkey; Ukraine; United Kingdom. Morbidity and mortality after anaesthesia in early life: results of the European prospective multicentre observational study, neonate and children audit of anaesthesia practice in Europe (NECTARINE). Br J Anaesth. 2021 Jun;126(6):1157-1172. doi: 10.1016/j.bja.2021.02.016. Epub 2021 Apr 1.

  PMID: 33812668 BACKGROUND

MeSH Terms

Interventions

Stimuli Responsive Polymers

Intervention Hierarchy (Ancestors)

Polymers; Macromolecular Substances; Smart Materials; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ian Yuan, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 27, 2023
• Study Start: February 3, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (1)