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

NCT ID: NCT05256264

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group

Sevoflurane

No interventions assigned to this group

Low dose ketamine group

Sevoflurane + 3µg/kg/min ketamine infusion

Ketamine

Intervention Type: DRUG

Ketamine infusion at different dose to observe EEG DSA changes

High dose ketamine group

Sevoflurane + 6µg/kg/min ketamine infusion

Ketamine

Intervention Type: DRUG

Ketamine infusion at different dose to observe EEG DSA changes

Interventions

Ketamine

Ketamine infusion at different dose to observe EEG DSA changes

Intervention Type: DRUG

Other Intervention Names

Ketamine Hydrochloride

Eligibility 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.)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien-Kun Ting, MD, PhD

Role: STUDY_CHAIR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, Beitou, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hui Zen Hee

Role: CONTACT

huizen.hee@gmail.com

+886928507736

Facility Contacts

Hui Zen Hee

Role: primary

+886928507736

Other Identifiers

2021-09-008BC

Identifier Type: -

Identifier Source: org_study_id