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Study on the Influencing Factors of Electroencephalogram Parameters Under Anesthesia

Sponsor
Tianjin Medical University Second Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04760028
Collaborator
(none)
80
Enrollment
1
Location
1
Arm
3
Actual Duration (Months)
27.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Adjusting the depth of anesthesia
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study on the Influencing Factors of Electroencephalogram Parameters Under Anesthesia
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
May 30, 2021
Actual Study Completion Date :
May 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: sevoflurane

Adjust sevoflurane concentration as required

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

Outcome Measures

Primary Outcome Measures

  1. Indicators for monitoring the depth of anesthesia in different age groups [three months]

    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

  2. Relationship between EEG information index and age [three months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. ASA Ⅰ ~ Ⅲ 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Hospital of Tianjin Medical University Tianjin China 300000

Sponsors and Collaborators

  • Tianjin Medical University Second Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tianjin Medical University Second Hospital
ClinicalTrials.gov Identifier:
NCT04760028
Other Study ID Numbers:
  • EEG
First Posted:
Feb 18, 2021
Last Update Posted:
Oct 27, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Anesthetics

Study Results

No Results Posted as of Oct 27, 2021