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Completed

NCT Number: NCT04760028

Study on the Influencing Factors of Electroencephalogram Parameters Under Anesthesia

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.

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Key information

Conditions

EEC

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Hospital of Tianjin Medical University

Tianjin, 300000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Adjusting the depth of anesthesia

Procedure

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Second Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 18, 2021
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.