Trials / Unknown
UnknownNCT05256264
Machine-learning Algorithm to Differentiate Intraoperative Ketamine Dosing Based on Electroencephalographic Density Spectrum Array Analysis
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (estimated)
- Sponsor
- Taipei Veterans General Hospital, Taiwan · Other Government
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Accepted
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"
Conditions
- Electroencephalographic Density Spectrum Array Analysis
- Density Spectrum Array
- Ketamine
- Multimodal General Anesthesia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ketamine | Ketamine infusion at different dose to observe EEG DSA changes |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2022-02-25
- Last updated
- 2022-08-17
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT05256264. Inclusion in this directory is not an endorsement.