Machine-learning Algorithm to Differentiate Intraoperative Ketamine Dosing Based on Electroencephalographic Density Spectrum Array Analysis
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Ketamine dosing based on EEG DSA
研究概览
简要总结
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.
详细描述
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"
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing elective spine surgery
- •Aged 20-80 years old
排除标准
- •Presence of major brain disorders: stroke, epilepsy, Parkinson's disease, etc.
- •Any of the following major organ disorders:
- •Chronic pulmonary disease (Clinically diagnosed severe chronic obstructive pulmonary disease or FEV1/FVC <70% or FEV1 <50%)
- •Heart failure (NYHA III or IV)
- •Chronic renal failure (eGFR<60ml/min/1.73m2)
- •Ongoing sepsis or infection
- •Ongoing of history of CNS-acting medications/substances use (e.g.: sedatives, hypnotics, stimulants, etc.)
研究组 & 干预措施
Low dose ketamine group
Sevoflurane + 3µg/kg/min ketamine infusion
干预措施: Ketamine (Drug)
High dose ketamine group
Sevoflurane + 6µg/kg/min ketamine infusion
干预措施: Ketamine (Drug)
结局指标
主要结局
Ketamine dosing based on EEG DSA
时间窗: 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.
次要结局
未报告次要终点