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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.
This is a study for comparison of incidence of EEG discontinuity during general anesthesia using sevoflurane. EEG guidance group will receive calibration of fraction of inhalational sevoflurane according to components of slow wave and delta wave of raw EEG. Control group will receive conventional management of anesthesia according to vital signs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroencephalogram | Experimental | Adjustment of concentration of sevoflurane according to EEG |
|
| Conventional | Active Comparator | Adjustment of concentration of sevoflurane according to vital signs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG guided anesthesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration of EEG discontinuity | Total sum of duration of EEG discontinuity | From start of anesthesia to end of study, Less than 24 hours |
| Significant isoelectric EEG | Incidence of significant isoelectric EEG (EEG amplitudes < 10uV for more than 2 seconds) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang-Hwan Ji, M.D., Ph.D. | Contact | +82-2-2072-3661 | taepoongshin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ji-Hyun Lee, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Other | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26102526 | 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. | |
| 29793594 | Background | 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. |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Conventional anesthesia | Procedure | 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. |
|
| From start of anesthesia to end of study, Less than 24 hours |
| EtSev | Mean end-tidal sevoflurane concentration during anesthesia | From start of anesthesia to end of study, Less than 24 hours |
| SEF | Mean spectral edge frequency value during anesthesia | From start of anesthesia to end of study, Less than 24 hours |
| PSi | Mean patient state index value during anesthesia | From start of anesthesia to end of study, Less than 24 hours |
| Mean blood pressure | Mean blood pressure values during anesthesia measured every 2.5 minutes | From start of anesthesia to end of study, Less than 24 hours |
| Heart rate | Heart rate values during anesthesia measured every 2.5 minutes | From start of anesthesia to end of study, Less than 24 hours |
| 25271891 | 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. |
| 26275092 | 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. |
| 21190458 | Background | 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. |
| 36774668 | Background | 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. |
| 35069132 | Background | 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. |
| 31107263 | 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. |
| 34938968 | Background | 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. |
| 28177176 | Background | 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. |
| 35503999 | 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. |
| 10740549 | 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. |
| 18337600 | 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. |
| 8024136 | 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. |
| 35041633 | Background | 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. |
| 29367620 | Background | 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. |