Machine-learning Algorithm to Differentiate Intraoperative Ketamine Dosing Based on Electroencephalographic Density Spectrum Array Analysis
Data Collection
Collected from today forward - ProspectiveOther
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: March 1, 2022
Actual date on which the first participant was enrolled.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"
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.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.)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location