Anesthesia and EEG Discontinuity in Infants

Anesthesia, General Clinical Trial

Official title:

The Impact of Electroencephalogram (EEG) - Guided Inhalational Anesthetic Control on the Occurrence of EEG Discontinuity in Infants: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05906225
• Other study ID #: 2304-138-1427
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: Sang-Hwan Ji, M.D., Ph.D.
• Phone: +82-2-2072-3661
• Email: taepoongshin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: May 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia, General
• Anesthesia, Inhalation
• Electroencephalography
• Infant
• Respiratory Aspiration

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Other

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total duration of EEG discontinuity	Total sum of duration of EEG discontinuity	From start of anesthesia to end of study, Less than 24 hours
Secondary	Significant isoelectric EEG	Incidence of significant isoelectric EEG (EEG amplitudes < 10uV for more than 2 seconds)	From start of anesthesia to end of study, Less than 24 hours
Secondary	EtSev	Mean end-tidal sevoflurane concentration during anesthesia	From start of anesthesia to end of study, Less than 24 hours
Secondary	SEF	Mean spectral edge frequency value during anesthesia	From start of anesthesia to end of study, Less than 24 hours
Secondary	PSi	Mean patient state index value during anesthesia	From start of anesthesia to end of study, Less than 24 hours
Secondary	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
Secondary	Heart rate	Heart rate values during anesthesia measured every 2.5 minutes	From start of anesthesia to end of study, Less than 24 hours