NCT05906225

Brief Summary

This study is a randomized controlled trial to evaluate whether EEG-guided calibration of inhalation agents can reduce occurrence of EEG discontinuity in infants during general anesthesia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

June 7, 2023

Last Update Submit

June 7, 2023

Conditions

Anesthesia, GeneralElectroencephalographyInfantAnesthesia, Inhalation

Keywords

ElectroencephalographyInfantGeneral anesthesiaBurst suppressionSevoflurane

Outcome Measures

Primary Outcomes (1)

  • EEG discontinuity

    Incidence of EEG discontinuity (EEG amplitudes \< 25uV for more than 2 seconds)

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

Secondary Outcomes (7)

  • Total duration of EEG discontinuity

    From start of anesthesia to end of study, Less than 24 hours

  • Significant isoelectric EEG

    From start of anesthesia to end of study, Less than 24 hours

  • EtSev

    From start of anesthesia to end of study, Less than 24 hours

  • SEF

    From start of anesthesia to end of study, Less than 24 hours

  • PSi

    From start of anesthesia to end of study, Less than 24 hours

  • +2 more secondary outcomes

Study Arms (2)

Electroencephalogram

EXPERIMENTAL

Adjustment of concentration of sevoflurane according to EEG

Procedure: EEG guided anesthesia

Conventional

ACTIVE COMPARATOR

Adjustment of concentration of sevoflurane according to vital signs

Procedure: Conventional anesthesia

Interventions

EEG guided anesthesiaPROCEDURE

Monitoring of electroencephalogram via Sedline probe by MASIMO corporation. Adjust concentration of inhalational sevoflurane during anesthesia, according to component of slow\&delta wave and alpha wave, so that slow/delta oscillation (with or without alpha oscillation) is maintained.

Electroencephalogram
Conventional anesthesiaPROCEDURE

Adjust concentration of inhalational sevoflurane during anesthesia, according to vital signs, so that mean blood pressure and heart rate are maintained between 80% and 120% of baseline values measured at ward before anesthesia.

Conventional

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants who were born as full-term (\>37 weeks postconception) and are equal to or less than 12 month old who were scheduled to undergo surgery under general anesthesia using inhalation agents.
  • Belongs to American Society of Anesthesiologists Physical Status 1 or 2

You may not qualify if:

  • Infants who were born less than 37 weeks postconception or has history of mechanical ventilation immediately after birth
  • Presence of any genetic disease, chromosomal anomaly or congenital anomaly that can affect brain development
  • Presence of any disease or disability in central nervous system
  • History of trauma at head or surgery on brain
  • History of hypersensitivity to any anesthetic agents
  • Status of sedation or endotracheal intubation before induction of anesthesia
  • Inability to attach probes for EEG monitoring
  • Expectation of operation time as less than 5 minutes
  • Other conditions that researchers regard as inappropriate for enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Other, 03080, South Korea

Location

Related Publications (16)

  • 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: 26102526BACKGROUND

  • Cornelissen L, Kim SE, Lee JM, Brown EN, Purdon PL, Berde CB. Electroencephalographic markers of brain development during sevoflurane anaesthesia in children up to 3 years old. Br J Anaesth. 2018 Jun;120(6):1274-1286. doi: 10.1016/j.bja.2018.01.037. Epub 2018 Apr 5.

    PMID: 29793594BACKGROUND

  • 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: 25271891BACKGROUND

  • 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: 26275092BACKGROUND

  • 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: 21190458BACKGROUND

  • Bong CL, Long MHY. Sevoflurane requirements during electroencephalogram (EEG)-guided vs standard anesthesia care in children: A randomized controlled trial. J Clin Anesth. 2023 Jun;86:111071. doi: 10.1016/j.jclinane.2023.111071. Epub 2023 Feb 13. No abstract available.

    PMID: 36774668BACKGROUND

  • Pawar N, Barreto Chang OL. Burst Suppression During General Anesthesia and Postoperative Outcomes: Mini Review. Front Syst Neurosci. 2022 Jan 7;15:767489. doi: 10.3389/fnsys.2021.767489. eCollection 2021.

    PMID: 35069132BACKGROUND

  • 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: 31107263BACKGROUND

  • Gao Z, Zhang J, Wang X, Yao M, Sun L, Ren Y, Qiu D. A retrospective study of electroencephalography burst suppression in children undergoing general anesthesia. Pediatr Investig. 2021 Aug 16;5(4):271-276. doi: 10.1002/ped4.12287. eCollection 2021 Dec.

    PMID: 34938968BACKGROUND

  • Cornelissen L, Bergin AM, Lobo K, Donado C, Soul JS, Berde CB. Electroencephalographic discontinuity during sevoflurane anesthesia in infants and children. Paediatr Anaesth. 2017 Mar;27(3):251-262. doi: 10.1111/pan.13061. Epub 2017 Feb 8.

    PMID: 28177176BACKGROUND

  • 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: 35503999BACKGROUND

  • 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: 10740549BACKGROUND

  • 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: 18337600BACKGROUND

  • 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: 8024136BACKGROUND

  • Chao JY, Gutierrez R, Legatt AD, Yozawitz EG, Lo Y, Adams DC, Delphin ES, Shinnar S, Purdon PL. Decreased Electroencephalographic Alpha Power During Anesthesia Induction Is Associated With EEG Discontinuity in Human Infants. Anesth Analg. 2022 Dec 1;135(6):1207-1216. doi: 10.1213/ANE.0000000000005864. Epub 2022 Nov 16.

    PMID: 35041633BACKGROUND

  • Lee HC, Jung CW. Vital Recorder-a free research tool for automatic recording of high-resolution time-synchronised physiological data from multiple anaesthesia devices. Sci Rep. 2018 Jan 24;8(1):1527. doi: 10.1038/s41598-018-20062-4.

    PMID: 29367620BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ji-Hyun Lee, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Hwan Ji, M.D., Ph.D.

CONTACT

+82-2-2072-3661taepoongshin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 15, 2023

Study Start

June 20, 2023

Primary Completion

March 30, 2025

Study Completion

May 30, 2025

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)