Study on the Influencing Factors of Electroencephalogram Parameters Under Anesthesia

EEC Clinical Trial

Official title:

Study on the Influencing Factors of Electroencephalogram Parameters Under Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04760028
• Other study ID #: EEG
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: May 30, 2021

Study information

• Verified date: October 2021
• Source: Tianjin Medical University Second Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In the process of general anesthesia, the reliable judgment of the depth of anesthesia has always been the focus of anesthesiologists.In recent decades, researchers have discovered that it is possible to monitor the effects of anesthesia using electroencephalography (EEG), so the information has come to be used to guide anesthesia management.The indicators derived from electroencephalogram (EEG) that can be used to judge the depth of anesthesia during general anesthesia, such as spectral edge frequency, burst inhibition rate, median power frequency, etc., were successively born. Thereafter, commercial instruments for monitoring the depth of anesthesia, such as EEG dual-frequency index, entropy module, Narcotrend index, etc., were also widely used in clinical practice.Although the anesthesia measurements or instrument has many advantages, but the use of these indicators are not considering the factors of age, and have been well documented for general anesthesia electroencephalography (eeg) of different ages is different, this means that in different age groups using the same monitoring indicators will lead to the judgment of anesthesia depth is larger error.Therefore, age should be considered in the process of monitoring the depth of clinical anesthesia, and appropriate indexes should be selected according to different ages to monitor the depth of anesthesia.However, it has not been thoroughly studied which indexes can be used to monitor the depth of anesthesia in each age group and how to conduct reasonable monitoring.Therefore, it is necessary to explore the monitoring indexes of depth of anesthesia in different age groups and the most appropriate monitoring program.

The purpose of this study was to validate EEG indicators that can monitor the depth of anesthesia at different ages, including basic EEG power spectrum parameters and processed parameters, and to explore whether there is an optimal protocol for monitoring the depth of anesthesia at different ages.In order to facilitate the clinical selection of patients of different age groups to monitor the depth of anesthesia, the factor of age is considered so as to take individual monitoring.Finally, it can accurately judge the depth of anesthesia and accurately use the anesthetic drugs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. ASA ? ~ ? level

2. 18 to 100 years

3. BMI 19 ~ 30 kg/m squared

4. Patients without intracranial surgery

Exclusion Criteria:

1. nervous system diseases, abnormal EEG, old cerebral infarction, the use of drugs affecting the nervous system;

2. coronary heart disease, hypertension without regular treatment or poor control;

3. The oxygen partial pressure and calcium ion levels were abnormal before anesthesia induction;

4. History of alcohol abuse.

Related Conditions & MeSH terms

• EEC

Intervention

Procedure:
• Adjusting the depth of anesthesia
After the main procedure, the depth of anesthesia can be adjusted as needed

Locations

Country	Name	City	State
China	The Second Hospital of Tianjin Medical University	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

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. Review. — View Citation

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

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

Kreuzer M, Stern MA, Hight D, Berger S, Schneider G, Sleigh JW, García 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. — View Citation

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. — View Citation

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. — View Citation

Otto KA, Cebotari S, Höffler 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. — View Citation

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. — View Citation

Smith WD, Dutton RC, Smith NT. Measuring the performance of anesthetic depth indicators. Anesthesiology. 1996 Jan;84(1):38-51. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indicators for monitoring the depth of anesthesia in different age groups	The absolute power of slow wave, d wave, ? wave, a wave, ß wave and ? wave in dB, the relative power of slow wave, d wave, ? wave, a wave, ß wave and ? 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
Primary	Relationship between EEG information index and age	The absolute power of slow wave, d wave, ? wave, a wave, ß wave and ? wave in dB, the relative power of slow wave, d wave, ? wave, a wave, ß wave and ? 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