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Machine-learning Algorithm to Differentiate Intraoperative Ketamine Dosing Based on Electroencephalographic Density Spectrum Array Analysis

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05256264
Collaborator
(none)
90
Enrollment
1
Location
10
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ketamine is widely used in the setting of multimodal general anesthesia, and the Electroencephalographic density spectral array (DSA) monitoring has been implemented in the practice of anesthesia. The purpose of this study is to investigate the dose-response EEG changes in patients during the perioperative period when ketamine is used. With the application of machine-learning algorithm, we aim to interpret the ketamine dosing precisely and accurately, based on the DSA obtained.

Condition or Disease Intervention/Treatment Phase

Detailed Description

In this single-blinded randomized controlled trial, we enroll 90 patients undergoing major spine surgery, and candidates are divided into 3 groups: A (control group using sevoflurane only), B (sevoflurane + 3µg/kg ketamine infusion), C (sevoflurane + 6µg/kg/min ketamine infusion). Throughout the perioperative period, under standardized perioperative care, each patient will be monitored with EEG DSA. The data obtained will be utilized for machine-learning in the development of a algorithm to interpret the precise dosing of ketamine in respect of its effect on the EEG DSA. This study is also anticipated to boost the development of dose-response algorithm of other agents, promoting the advancement of the concept of "multimodal general anesthesia"

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Machine-learning Algorithm to Differentiate Intraoperative Ketamine Dosing Based on Electroencephalographic Density Spectrum Array Analysis
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Control group

Sevoflurane
Low dose ketamine group

Sevoflurane + 3µg/kg/min ketamine infusion

Drug: Ketamine
Ketamine infusion at different dose to observe EEG DSA changes
Other Names:
  • Ketamine Hydrochloride

    		•
    High dose ketamine group

    Sevoflurane + 6µg/kg/min ketamine infusion

    Drug: Ketamine
    Ketamine infusion at different dose to observe EEG DSA changes
    Other Names:
  • Ketamine Hydrochloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ketamine dosing based on EEG DSA [DSA EEG is placed before anesthesia starts, recorded throughout the operative procedure until emergence and patient is extubated. The saved EEG DSA data will be retrieved by the end of the day.]

      The DSA is obtained from raw EEG by fast Fourier transformation. By interpreting the DSA, we can obtain the trends and changes of power within different frequencies over time, in respect to different ketamine dosing.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Patients undergoing elective spine surgery

    2. Aged 20-80 years old

    Exclusion Criteria:

    1. Pregnancy

    2. Presence of major brain disorders: stroke, epilepsy, Parkinson's disease, etc.

    3. Any of the following major organ disorders:

    4. Chronic pulmonary disease (Clinically diagnosed severe chronic obstructive pulmonary disease or FEV1/FVC <70% or FEV1 <50%)

    5. Heart failure (NYHA III or IV)

    6. Chronic renal failure (eGFR<60ml/min/1.73m2)

    7. Ongoing sepsis or infection

    8. Ongoing of history of CNS-acting medications/substances use (e.g.: sedatives, hypnotics, stimulants, etc.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Veterans General Hospital Taipei Beitou Taiwan 112

    Sponsors and Collaborators

    • Taipei Veterans General Hospital, Taiwan

    Investigators

    • Study Chair: Chien-Kun Ting, MD, PhD, Taipei Veterans General Hospital, Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taipei Veterans General Hospital, Taiwan
    ClinicalTrials.gov Identifier:
    NCT05256264
    Other Study ID Numbers:
    • 2021-09-008BC
    First Posted:
    Feb 25, 2022
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Taipei Veterans General Hospital, Taiwan
    General anesthesia
    Ketamine
    Density Spectrum Array
    Electroencephalogram
    Multimodal General Anesthesia
    Machine learning
    Additional relevant MeSH terms:
    Ketamine

    Study Results

    No Results Posted as of Aug 17, 2022