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

Ketamine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256264
• Other study ID #: 2021-09-008BC
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Hui Zen Hee
• Phone: +886928507736
• Email: huizen.hee[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Ketamine

Intervention

Drug:
• Ketamine
Ketamine infusion at different dose to observe EEG DSA changes

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei	Beitou

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.