An observational study in Electroencephalographic Density Spectrum Array Analysis, Density Spectrum Array and Ketamine, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by Taipei Veterans General Hospital, Taiwan · Observational
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.
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"
Taipei Veterans General Hospital, Taiwan is the lead sponsor of 338 studies on the registry; 74 are open to participants now.
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Patients admitted for spine surgery under the department of orthopedic surgery at VGHTPE, a tertiary hospital in Taiwan, will be selected.
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Exclusion Criteria:
Any of the following major organ disorders:
Sevoflurane
Sevoflurane + 3µg/kg/min ketamine infusion
Drug: Ketamine
Sevoflurane + 6µg/kg/min ketamine infusion
Drug: Ketamine
Ketamine infusion at different dose to observe EEG DSA changes
Also known as: Ketamine Hydrochloride
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.
Time frame: 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.
Started Mar 2022 (actual). Primary completion is estimated for Dec 2022, 9 months after the start.
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Taipei Veterans General Hospital, Taiwan →