Study on the Influencing Factors of Electroencephalogram Parameters Under Anesthesia

NCT04760028 | Completed Phase 4

• 1 other identifier: EEG
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The depth of anaesthesia is affected by the age factor in the interpretation of EEG information. Only by fully considering the influence of the age factor can we accurately grasp the depth of anaesthesia.

Conditions

EEC

Outcome Measures

Primary Outcomes (2)

• Indicators for monitoring the depth of anesthesia in different age groups

  The absolute power of slow wave, δ wave, θ wave, α wave, β wave and γ wave in dB, the relative power of slow wave, δ wave, θ wave, α wave, β wave and γ wave in %, the approximate entropy, sequence entropy and sample entropy without unit, and the double coherence without unit in monitoring the depth of anesthesia in different ages

  three months

• Relationship between EEG information index and age

  The absolute power of slow wave, δ wave, θ wave, α wave, β wave and γ wave in dB, the relative power of slow wave, δ wave, θ wave, α wave, β wave and γ wave in %, there is no unit of approximate entropy, sequence entropy, sample entropy, double coherence and the relationship between age and depth of anesthesia

  three months

Study Arms (1)

sevoflurane

OTHER

Adjust sevoflurane concentration as required

Procedure: Adjusting the depth of anesthesia

Interventions

Adjusting the depth of anesthesia PROCEDURE

After the main procedure, the depth of anesthesia can be adjusted as needed

sevoflurane

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Ⅰ \~ Ⅲ level
• to 100 years
• BMI 19 \~ 30 kg/m squared
• Patients without intracranial surgery

You may not qualify if:

• nervous system diseases, abnormal EEG, old cerebral infarction, the use of drugs affecting the nervous system;
• coronary heart disease, hypertension without regular treatment or poor control;
• The oxygen partial pressure and calcium ion levels were abnormal before anesthesia induction;
• History of alcohol abuse.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

The Second Hospital of Tianjin Medical University

Tianjin, 300000, China

Location

Related Publications (12)

• Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.

  PMID: 15616043 BACKGROUND

• Brown EN, Purdon PL. The aging brain and anesthesia. Curr Opin Anaesthesiol. 2013 Aug;26(4):414-9. doi: 10.1097/ACO.0b013e328362d183.

  PMID: 23820102 BACKGROUND

• Bennett C, Voss LJ, Barnard JP, Sleigh JW. Practical use of the raw electroencephalogram waveform during general anesthesia: the art and science. Anesth Analg. 2009 Aug;109(2):539-50. doi: 10.1213/ane.0b013e3181a9fc38.

  PMID: 19608830 BACKGROUND

• Otto KA, Cebotari S, Hoffler HK, Tudorache I. Electroencephalographic Narcotrend index, spectral edge frequency and median power frequency as guide to anaesthetic depth for cardiac surgery in laboratory sheep. Vet J. 2012 Mar;191(3):354-9. doi: 10.1016/j.tvjl.2011.02.023. Epub 2011 Mar 30.

  PMID: 21454112 BACKGROUND

• Schultz A, Siedenberg M, Grouven U, Kneif T, Schultz B. Comparison of Narcotrend Index, Bispectral Index, spectral and entropy parameters during induction of propofol-remifentanil anaesthesia. J Clin Monit Comput. 2008 Apr;22(2):103-11. doi: 10.1007/s10877-008-9111-6. Epub 2008 Feb 21.

  PMID: 18288579 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.

  PMID: 18337600 BACKGROUND

• Hayashi K, Indo K, Sawa T. Anaesthesia-dependent oscillatory EEG features in the super-elderly. Clin Neurophysiol. 2020 Sep;131(9):2150-2157. doi: 10.1016/j.clinph.2020.05.027. Epub 2020 Jun 23.

  PMID: 32682243 BACKGROUND

• Kreuzer M, Stern MA, Hight D, Berger S, Schneider G, Sleigh JW, Garcia PS. Spectral and Entropic Features Are Altered by Age in the Electroencephalogram in Patients under Sevoflurane Anesthesia. Anesthesiology. 2020 May;132(5):1003-1016. doi: 10.1097/ALN.0000000000003182.

  PMID: 32108685 BACKGROUND

• Aranake A, Mashour GA, Avidan MS. Minimum alveolar concentration: ongoing relevance and clinical utility. Anaesthesia. 2013 May;68(5):512-22. doi: 10.1111/anae.12168. Epub 2013 Feb 16.

  PMID: 23414556 BACKGROUND

• Blain-Moraes S, Tarnal V, Vanini G, Alexander A, Rosen D, Shortal B, Janke E, Mashour GA. Neurophysiological correlates of sevoflurane-induced unconsciousness. Anesthesiology. 2015 Feb;122(2):307-16. doi: 10.1097/ALN.0000000000000482.

  PMID: 25296108 BACKGROUND

• Smith WD, Dutton RC, Smith NT. Measuring the performance of anesthetic depth indicators. Anesthesiology. 1996 Jan;84(1):38-51. doi: 10.1097/00000542-199601000-00005.

  PMID: 8572353 BACKGROUND

• Li X, Li D, Liang Z, Voss LJ, Sleigh JW. Analysis of depth of anesthesia with Hilbert-Huang spectral entropy. Clin Neurophysiol. 2008 Nov;119(11):2465-75. doi: 10.1016/j.clinph.2008.08.006. Epub 2008 Sep 21.

  PMID: 18812265 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 18, 2021
• Study Start: March 1, 2023
• Primary Completion: January 10, 2024
• Study Completion: March 30, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)