Frequency Analysis of Raw EEG During Sevoflurane Anesthesia in Children Younger Than 2 Years Old

NCT05148065 | Completed FDA Device

• 1 other identifier: 2109-164-1260
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze raw electroencephalogram in infants younger than 2 years old undergoing general anesthesia using sevoflurane.

Conditions

Anesthesia, General; Sevoflurane; Infant

Keywords

Electroenphalography; Frequency analysis

Outcome Measures

Primary Outcomes (1)

• Frequency analysis

  Distribution of raw electroencephalogram waves along frequency bands according to state of anesthesia

  From start of anesthesia to end of anesthesia, less than 24 hours

Secondary Outcomes (3)

• Prediction probability

  From start of anesthesia to end of anesthesia, less than 24 hours

• Coherence of BIS and PSi

  From start of anesthesia to end of anesthesia, less than 24 hours

• Emergence delirium and frequency analysis

  From start of anesthesia to end of anesthesia, less than 24 hours

Interventions

BIS DEVICE

Bispectral index monitoring

PSi DEVICE

Patient state index monitoring

Eligibility Criteria

• Age: 4 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged between 4 months and 2 years planned to undergo surgery under general anesthesia, whose American Society of Anesthesiologists physical status are 1 or 2

You may qualify if:

• Pediatric patients aged between 4 months and 2 years planned to undergo surgery under general anesthesia
• American Society of Anesthesiologists physical status 1 or 2

You may not qualify if:

• History of preterm birth (postconceptual age \< 32 wks) or history of mechanical ventilation immediately after birth
• Presence of genetic disease or chromosomal abnormality that can affect brain development
• Presence of disease in central nervous system
• History of head trauma or surgery involving head
• History of hypersensitivity to anesthetic drugs
• Intubated or sedated state before induction of anesthesia
• Difficulty in attaching both the bispectral index and patient state index probes to patient's forehead
• Expected operation time of less than 5 minutes

Sponsors & Collaborators

• Sang-Hwan Ji: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (12)

• Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.

  PMID: 21190458 BACKGROUND

• Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.

  PMID: 15172773 BACKGROUND

• Soehle M, Ellerkmann RK, Grube M, Kuech M, Wirz S, Hoeft A, Bruhn J. Comparison between bispectral index and patient state index as measures of the electroencephalographic effects of sevoflurane. Anesthesiology. 2008 Nov;109(5):799-805. doi: 10.1097/ALN.0b013e3181895fd0.

  PMID: 18946290 BACKGROUND

• Soehle M, Kuech M, Grube M, Wirz S, Kreuer S, Hoeft A, Bruhn J, Ellerkmann RK. Patient state index vs bispectral index as measures of the electroencephalographic effects of propofol. Br J Anaesth. 2010 Aug;105(2):172-8. doi: 10.1093/bja/aeq155. Epub 2010 Jun 29.

  PMID: 20587537 BACKGROUND

• Koch S, Stegherr AM, Morgeli R, Kramer S, Toubekis E, Lichtner G, von Dincklage F, Spies C. Electroencephalogram dynamics in children during different levels of anaesthetic depth. Clin Neurophysiol. 2017 Oct;128(10):2014-2021. doi: 10.1016/j.clinph.2017.07.417. Epub 2017 Aug 9.

  PMID: 28837907 BACKGROUND

• Tokuwaka J, Satsumae T, Mizutani T, Yamada K, Inomata S, Tanaka M. The relationship between age and minimum alveolar concentration of sevoflurane for maintaining bispectral index below 50 in children. Anaesthesia. 2015 Mar;70(3):318-22. doi: 10.1111/anae.12890. Epub 2014 Oct 1.

  PMID: 25271891 BACKGROUND

• Cornelissen L, Kim SE, Purdon PL, Brown EN, Berde CB. Age-dependent electroencephalogram (EEG) patterns during sevoflurane general anesthesia in infants. Elife. 2015 Jun 23;4:e06513. doi: 10.7554/eLife.06513.

  PMID: 26102526 BACKGROUND

• Kim J, Lee HC, Byun SH, Lim H, Lee M, Choung Y, Kim E. Frontal electroencephalogram activity during emergence from general anaesthesia in children with and without emergence delirium. Br J Anaesth. 2021 Jan;126(1):293-303. doi: 10.1016/j.bja.2020.07.060. Epub 2020 Oct 1.

  PMID: 33010926 BACKGROUND

• Eagleman SL, Drover CM, Li X, MacIver MB, Drover DR. Offline comparison of processed electroencephalogram monitors for anaesthetic-induced electroencephalogram changes in older adults. Br J Anaesth. 2021 May;126(5):975-984. doi: 10.1016/j.bja.2020.12.042. Epub 2021 Feb 25.

  PMID: 33640118 BACKGROUND

• Seo KH, Kim KM, Lee SK, John H, Lee J. Comparative Analysis of Phase Lag Entropy and Bispectral Index as Anesthetic Depth Indicators in Patients Undergoing Thyroid Surgery with Nerve Integrity Monitoring. J Korean Med Sci. 2019 May 27;34(20):e151. doi: 10.3346/jkms.2019.34.e151.

  PMID: 31124327 BACKGROUND

• Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.

  PMID: 18337600 BACKGROUND

• Katoh T, Kobayashi S, Suzuki A, Kato S, Iwamoto T, Bito H, Sato S. Fentanyl augments block of sympathetic responses to skin incision during sevoflurane anaesthesia in children. Br J Anaesth. 2000 Jan;84(1):63-6. doi: 10.1093/oxfordjournals.bja.a013384.

  PMID: 10740549 BACKGROUND

Study Officials

• Sang-Hwan Ji, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: December 15, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)