Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2023-06-20
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Electroencephalogram
Adjustment of concentration of sevoflurane according to EEG
EEG guided anesthesia
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.
Conventional
Adjustment of concentration of sevoflurane according to vital signs
Conventional anesthesia
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.
Interventions
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EEG guided anesthesia
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.
Conventional anesthesia
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.
Eligibility Criteria
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Inclusion Criteria
* Belongs to American Society of Anesthesiologists Physical Status 1 or 2
Exclusion Criteria
* 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
12 Months
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Ji-Hyun Lee
Clinical Associate Professor
Principal Investigators
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Ji-Hyun Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Other, South Korea
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2304-138-1427
Identifier Type: -
Identifier Source: org_study_id
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