Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03679390 |
Other study ID # |
201605031RINC |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2017 |
Est. completion date |
September 1, 2020 |
Study information
Verified date |
June 2020 |
Source |
National Taiwan University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The electroencephalography (EEG) is a noninvasive medical technique for monitoring and
recording the electrical activity of brain. The Hilbert-Huang Transformation (HHT) was
proposed to decompose EEG signal into intrinsic mode functions (IMF). HHT can obtain
instantaneous frequency data and work well for nonstationary and nonlinear data. We applied
this method in perioperative EEG signal analysis in order to find the energy shift and
quantify the energy change during general anesthesia. Ketamine was a depolarized sedative
which was wildly used in anesthesia. We are trying to find the energy change after ketamine
injection, and the interaction between different oscillations in EEG. The whole brain mapping
for ketamine and other sedatives interaction is the next step.
Description:
Method: In the first year, we will record 60 patients who received general anesthesia, their
EEG data recorded from bi-spectral index (BIS) monitor. Under the same anesthesia depth, the
experimental group use ketamine 0.5mg/kg; while the control group using alfentanil 0.01mg/kg
injection. Both perioperative data were recorded included heart rate, blood pressure and
surgical time. We decompose the raw EEG data from BIS monitor with EMD, and we observe
difference between IMFs, and quantifying energy change. Second year: We will extend the EEG
monitor to temporal lobe, parietal lobe and occipital lobe. Besides the whole brain mapping
method for detecting energy change after ketamine injection; we also tried to find the
interactions between oscillations. Finally, we want to apply the analysis method to pediatric
patients, try to find the difference of ketamine reaction between generations. Anticipated
Results: We anticipate that we can quantify the energy of EEG by Emperical mode
decomposition(EMD), and ketamine injection can cause different energy change with other
sedatives. We will find the energy traveling in EEG with EMD decomposition. We will find that
HHT is more suitable for EEG analysis in clinical practicing. With the whole brain mapping
method, we can understand the electrical activity during general anesthesia.