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TerminatedNCT03679390Updated Jul 6, 2021

The Electroencephalogram and Clinical Effect of Ketamine

An interventional study of Ketamine in Electroencephalogram and Consciousness, Loss of, sponsored by National Taiwan University Hospital. Terminated at 1 site in Taiwan. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2021-07-06.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Other

Why this study was terminated
no funding

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Mar 2017, registered Sep 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
10 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Electroencephalogram
  • Consciousness, Loss of

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03

In context

Unconsciousness

89 studies on the registry are indexed under Unconsciousness; 11 are open to participants now.

This study's enrollment of 17 is below the median of 51 across 56 interventional studies indexed under Unconsciousness.

Browse Unconsciousness studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
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

Exclusion Criteria:

patient refuse not suitable for propofol or ketamine injection

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
17 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugKetamine

    With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.

    Also known as: control

06

What researchers measure

Primary outcomes

  1. Ketamine increase the dissociation energy in EEG

    ANOVA measurement

    Time frame: one year

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03679390
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Sep 20, 2018
Start date
Mar 1, 2017
Primary completion
Sep 1, 2020
Completion
Sep 1, 2020
Last update
Jul 6, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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