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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03303443
Other study ID # 201508007RIN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2016
Est. completion date June 15, 2019

Study information

Verified date April 2019
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bispectral index (BIS), a standard monitor for perioperative monitor of patient's conscious level, is a noninvasive medical technique for monitoring and recording the electrical activity of brain.


Description:

The electroencephalogram and BIS data have lots of information. Fourier transformation to decompose EEG was first applied on the EEG signaling until now. The disadvantages of Fourier transformation is hard to deal with physical signals, which was modulated by autonomic system and factors. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF) since 2004. HHT can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear. HHT have been applied for wild ranges, not only in the analysis of arrhythmia for medical and public health fields, but also in the earthquake detection and earth physics detection…etc.

The relationship between frontal EEG patterns and general anesthesia remain poorly understood. It can only say that the increase in frontal EEG power and shift power to lower frequencies during general anesthesia from publications. The investigators are going to compare the EEG signal between generations, try to find the difference in aging using empirical mode decomposition method.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 15, 2019
Est. primary completion date June 15, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

1. 20-40y/o or over 60y/o

2. Scheduled for low risk general anesthesia

3. Suitable for surgery after interviewed by anesthesiologist

Exclusion Criteria:

1. Not suitable for general anesthesia

2. High risk patient

3. Allergic to the EEG sensor

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Feng-Fang Tsai Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary EEG power calculation The investigator use root mean square energy to calculate EEG power. During the operation time.
See also
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Completed NCT04774120 - Relationship Between Bispectral Index, EEG Features, and Propofol Effect-site Concentration in Young and Elderly Patients.
Completed NCT03066024 - Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth