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

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ClinicalTrials.gov Identifier: NCT05256264
Recruitment Status : Recruiting
First Posted : February 25, 2022
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Tracking Information
First Submitted Date February 15, 2022
First Posted Date February 25, 2022
Last Update Posted Date February 25, 2022
Estimated Study Start Date March 1, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2022)
Ketamine dosing based on EEG DSA [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Machine-learning Algorithm to Differentiate Intraoperative Ketamine Dosing Based on Electroencephalographic Density Spectrum Array Analysis
Official Title Machine-learning Algorithm to Differentiate Intraoperative Ketamine Dosing Based on Electroencephalographic Density Spectrum Array Analysis
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients admitted for spine surgery under the department of orthopedic surgery at VGHTPE, a tertiary hospital in Taiwan, will be selected.
Condition
  • Electroencephalographic Density Spectrum Array Analysis
  • Density Spectrum Array
  • Ketamine
  • Multimodal General Anesthesia
Intervention Drug: Ketamine
Ketamine infusion at different dose to observe EEG DSA changes
Other Name: Ketamine Hydrochloride
Study Groups/Cohorts
  • Control group
    Sevoflurane
  • Low dose ketamine group
    Sevoflurane + 3µg/kg/min ketamine infusion
    Intervention: Drug: Ketamine
  • High dose ketamine group
    Sevoflurane + 6µg/kg/min ketamine infusion
    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 Recruiting
Estimated Enrollment
 (submitted: February 24, 2022)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

    1. Chronic pulmonary disease (Clinically diagnosed severe chronic obstructive pulmonary disease or FEV1/FVC <70% or FEV1 <50%)
    2. Heart failure (NYHA III or IV)
    3. Chronic renal failure (eGFR<60ml/min/1.73m2)
  4. Ongoing sepsis or infection
  5. Ongoing of history of CNS-acting medications/substances use (e.g.: sedatives, hypnotics, stimulants, etc.)
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Hui Zen Hee +886928507736 huizen.hee@gmail.com
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT05256264
Other Study ID Numbers 2021-09-008BC
Has Data Monitoring Committee Yes
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 Not Provided
Current Responsible Party Taipei Veterans General Hospital, Taiwan
Original Responsible Party Same as current
Current Study Sponsor Taipei Veterans General Hospital, Taiwan
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Chien-Kun Ting, MD, PhD Taipei Veterans General Hospital, Taiwan
PRS Account Taipei Veterans General Hospital, Taiwan
Verification Date September 2021