Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Electroencephalogram and Clinical Effect of Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679390
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE September 19, 2018
First Posted Date  ICMJE September 20, 2018
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2018)
Ketamine increase the dissociation energy in EEG [ Time Frame: one year ]
ANOVA measurement
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Electroencephalogram and Clinical Effect of Ketamine
Official Title  ICMJE The Effect of Ketamine Between Generations in Operation Theater- Focus on Electroencephalogram Changes
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Use same medication for different generations, focus on the reactions.
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Electroencephalogram
  • Consciousness, Loss of
Intervention  ICMJE Drug: Ketamine
With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.
Other Name: control
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ketamine
  • 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.
    Intervention: Drug: Ketamine
  • 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.
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Feng-Fang Tsai 0972653390 fengfung@ntuh.gov.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03679390
Other Study ID Numbers  ICMJE 201605031RINC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP