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

Anesthesia, General Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148065
• Other study ID #: 2109-164-1260
• Status: Completed
• Start date: December 15, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 23 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia, General
• Infant
• Sevoflurane

Intervention

Device:
• BIS
Bispectral index monitoring
• PSi
Patient state index monitoring

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sang-Hwan Ji

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (12)

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

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

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

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. — 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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency analysis	Distribution of raw electroencephalogram waves along frequency bands according to state of anesthesia	From start of anesthesia to end of anesthesia, less than 24 hours
Secondary	Prediction probability	Prediction probability of bispectral index and patient state index for maintenance of surgical state of anesthesia	From start of anesthesia to end of anesthesia, less than 24 hours
Secondary	Coherence of BIS and PSi	Coherence of BIS and PSi for prediction of state of anesthesia	From start of anesthesia to end of anesthesia, less than 24 hours
Secondary	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	From start of anesthesia to end of anesthesia, less than 24 hours