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The Electroencephalogram and Clinical Effect of Ketamine

Primary Purpose

Electroencephalogram, Consciousness, Loss of

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ketamine
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Electroencephalogram

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

10-20 y/o

20-40y/o group

>70 y/o

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Ketamine increase the dissociation energy in EEG
ANOVA measurement

Secondary Outcome Measures

Full Information

First Posted
September 19, 2018
Last Updated
July 2, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03679390
Brief Title
The Electroencephalogram and Clinical Effect of Ketamine
Official Title
The Effect of Ketamine Between Generations in Operation Theater- Focus on Electroencephalogram Changes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
no funding
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electroencephalogram, Consciousness, Loss of

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Use same medication for different generations, focus on the reactions.
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10-20 y/o
Arm Type
Experimental
Arm Description
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.
Arm Title
20-40y/o group
Arm Type
Experimental
Arm Description
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.
Arm Title
>70 y/o
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
control
Intervention Description
With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.
Primary Outcome Measure Information:
Title
Ketamine increase the dissociation energy in EEG
Description
ANOVA measurement
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Electroencephalogram and Clinical Effect of Ketamine

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