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Feasibility of Closed-loop TCI Based on New BIS Baseline in the Presence of Low Dose of Esketamine: a Randomized Controlled Equivalence Trial.
The propofol-remifentanil closed-loop TCI system based on EEG guidance has been clinically verified, which enables more precise anesthetic dosing. As an adjunct to anesthesia, esketamine has been shown to stabilize hemodynamics, reduce opioid use, and reduce postoperative nausea and vomiting. However, due to its specific electroencephalographic excitatory effect, esketmine's clinical use in close-loop system has been limited. The aim of this experiment was to determine the specific impact of esketamine on EEG and thus obtain a new EEG baseline for close-loop system, which can broaden the application of close-loop TCI system in combination with other drugs.
The trial is devided into two phases. In the first phase, we statistically analyzed and calculated the changes of BIS by collecting a sample size of EEG changes after administering low dose of esketamine. We used 0.2 mg/kg as a loading dose and followed by a rate of 5ug/kg/min as esketamine administration and observe the changes in BIS each for 30 minutes. In the second phase, we obtain the BIS quantification value N with the addition of a small dose of esketamine in the first phase and thus obtain a new EEG baseline 50+N. By comparing this EEG-adjusted group with the control group, which run the close-loop system based on original BIS baseline without esketamine, whether the closed-loop system can be better applied based on the new BIS baseline under low dose of esketamine.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
Start Date
January 20, 2025
Primary Completion Date
April 30, 2025
Completion Date
May 30, 2025
Last Updated
January 13, 2025
120
ESTIMATED participants
Esketamine at low dose
DRUG
new BIS baseline
DEVICE
an equivalent dose of saline
DRUG
original BIS baseline
DEVICE
Lead Sponsor
bo xu
NCT05638490
NCT04375917
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04370990