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The Electroencephalogram and Clinical Effect of Ketamine

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03679390
Collaborator
(none)
17
Enrollment
1
Location
3
Arms
42.1
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Use same medication for different generations, focus on the reactions.Use same medication for different generations, focus on the reactions.
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Effect of Ketamine Between Generations in Operation Theater- Focus on Electroencephalogram Changes
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Sep 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 10-20 y/o

We will include the teenagers who need intravenous general anesthesia(IVGA), and inject propofol with/without ketamine 0.5mg/kg with full monitor. We will record the EEG during the who operation.

Drug: Ketamine
With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.
Other Names:
  • control

    		•
    Experimental: 20-40y/o group

    We will include patients who need IVGA, and inject propofol with/without ketamine 0.5mg/kg with full monitor. We will record the EEG during the who operation.

    Drug: Ketamine
    With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.
    Other Names:
  • control

    		•
    Experimental: >70 y/o

    We will include patients who need IVGA, and inject propofol with/without ketamine 0.5mg/kg with full monitor. We will record the EEG during the who operation.

    Drug: Ketamine
    With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.
    Other Names:
  • control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ketamine increase the dissociation energy in EEG [one year]

      ANOVA measurement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    American Society of Anesthesiology I-II Not allergic to BIS probe Do not have wound or scar over forehead area

    Exclusion Criteria:

    patient refuse not suitable for propofol or ketamine injection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03679390
    Other Study ID Numbers:
    • 201605031RINC
    First Posted:
    Sep 20, 2018
    Last Update Posted:
    Jul 6, 2021
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Unconsciousness
    Ketamine

    Study Results

    No Results Posted as of Jul 6, 2021