Study on the Influencing Factors of Electroencephalogram Parameters Under Anesthesia

October 26, 2021 updated by: Tianjin Medical University Second Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China, 300000
        • The Second Hospital Of Tianjin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indicators for monitoring the depth of anesthesia in different age groups
Time Frame: 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
three months
Relationship between EEG information index and age
Time Frame: 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
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Second Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 14, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EEG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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