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

NCT05256264 | Unknown DMC

• 1 other identifier: 2021-09-008BC
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Electroencephalographic Density Spectrum Array Analysis; Density Spectrum Array; Ketamine; Multimodal General Anesthesia

Keywords

General anesthesia; Ketamine; Density Spectrum Array; Electroencephalogram; Multimodal General Anesthesia; Machine learning

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Control group

Sevoflurane

Low dose ketamine group

Sevoflurane + 3µg/kg/min ketamine infusion

Drug: Ketamine

High dose ketamine group

Sevoflurane + 6µg/kg/min ketamine infusion

Drug: Ketamine

Interventions

Ketamine DRUG

Ketamine infusion at different dose to observe EEG DSA changes

Also known as: Ketamine Hydrochloride

High dose ketamine group; Low dose ketamine group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted for spine surgery under the department of orthopedic surgery at VGHTPE, a tertiary hospital in Taiwan, will be selected.

You may qualify if:

• Patients undergoing elective spine surgery
• Aged 20-80 years old

You may not qualify if:

• Pregnancy
• 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.)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou, 112, Taiwan

RECRUITING

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Chien-Kun Ting, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Central Study Contacts

Hui Zen Hee

CONTACT

+886928507736; huizen.hee@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 25, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

TW (1)