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AzTrials

Anesthesia, GeneralNCT05148065

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

An observational study of Anesthesia, General and Sevoflurane, run by Sang-Hwan Ji at 1 site in South Korea.

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

Who is it for?
Ages 4 to 23 months
Conditions the study is for
Anesthesia, General, Sevoflurane, Infant
What is being tested?
BIS and PSi
Type of treatment
Medical device
How many people
50 participants
Where
1 siteSouth Korea
Study dates
15 Dec 2021to 15 May 2023
Phase
Observational
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 4 to 23 months
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Analysis of Relationship Between Depth of Anesthesia by Inhalation Anesthetic and Primitive Electroencephalogram in Children Under Two Years of Age: a Prospective Observational Study

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

Read the detailed description

After obtaining an informed consent from one of the parents, patients undergo routine anesthetic induction using sodium thiopental. Bispectral index and patient state index are both monitored simultaneously. Raw electroencephalogram data are transmitted and recorded via a dedicated equipment. Anesthesia is maintained using sevoflurane with end-tidal level of less than 2 minimum alveolar concentration (MAC) adjusted to age. Fentanyl of up to 1 mcg/kg can be administered in case of increased heart rate and mean blood pressure with a degree of 30% of baseline.

During anesthesia, patients' status of sedation is defined as 'maintenance of surgical state of anesthesia (MOSSA)' when the end-tidal concentration of sevoflurane is maintained between 0.7 and 1.3 MAC and mean blood pressure and heart rate is between 80-120% of baseline.

'Emergence' is defined as a 3-minute period in the middle of continuous decrease in end-tidal concentration of sevoflurane in the range of less than 0.7 MAC and finally reaching 0.2 MAC.

Raw electroencephalogram waves are analyzed by distribution of power along frequency bands and compared according to the state of anesthesia or bispectral index / patient state index value.

Being tested
BIS, PSi
Keywords
Electroenphalography, Frequency analysis

What participants receive

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

  • BISDevice

    Bispectral index monitoring

  • PSiDevice

    Patient state index monitoring

What is being measured

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

  1. Frequency analysis

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

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

Secondary outcomes (3)

  1. Prediction probability

    Prediction probability of bispectral index and patient state index for maintenance of surgical state of anesthesia

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

  2. Coherence of BIS and PSi

    Coherence of BIS and PSi for prediction of state of anesthesia

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

  3. Emergence delirium and frequency analysis

    Relationship of distribution of electroencephalogram along frequency band at the 'emergence' state and appearance of emergence delirium at the postanesthesia care unit

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

Timeline

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

  1. First posted8 Dec 2021
  2. Study start15 Dec 2021
  3. Primary completion15 May 2023
  4. Study completion15 May 2023

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05148065
Sponsor's protocol ID
2109-164-1260
Status last verified
Jun 2023
First submitted
24 Nov 2021
Last updated
9 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 21190458

  • 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.

    PubMed 15172773

  • 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.

    PubMed 18946290

  • 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.

    PubMed 20587537

  • 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.

    PubMed 28837907

  • 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.

    PubMed 25271891

  • 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.

    PubMed 26102526

  • 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.

    PubMed 33010926

  • 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.

    PubMed 33640118

  • 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.

    PubMed 31124327

  • 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.

    PubMed 18337600

  • 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.

    PubMed 10740549

  • Yoon SB, Park JB, Kang P, Jang YE, Kim EH, Lee JH, Lee HC, Kim JT, Kim HS, Ji SH. Electroencephalography and Anesthetic Depth in Children Under 2 Years of Age: A Prospective Observational Study. Paediatr Anaesth. 2025 Apr;35(4):294-301. doi: 10.1111/pan.15058. Epub 2024 Dec 26.

    PubMed 39723638

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, General and Sevoflurane, run by Sang-Hwan Ji at 1 site in South Korea.

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 2 inclusion and 8 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 9 Jun 2023. 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 South Korea. 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?

Frequency analysis (time frame: From start of anesthesia to end of anesthesia, less than 24 hours). 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 NCT05148065, which also lists 13 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 9 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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