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

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.

Study Overview

• Status: Recruiting
• Conditions: Ketamine; Electroencephalographic Density Spectrum Array Analysis; Density Spectrum Array; Multimodal General Anesthesia
• Intervention / Treatment: Drug: Ketamine

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
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Hui Zen Hee; Phone Number: +886928507736; Email: huizen.hee@gmail.com

Study Locations

• Taiwan
  • Beitou
    • Taipei, Beitou, Taiwan, 112
      • Recruiting
      • Taipei Veterans General Hospital
      • Contact: Hui Zen Hee; Phone Number: +886928507736

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ketamine dosing based on EEG DSA	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.	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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Ketamine; Electroencephalogram; Machine learning; General anesthesia; Density Spectrum Array; Multimodal General Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 2021-09-008BC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No