Feasibility of Closed-Loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine: A Randomized Controlled Equivalence Trial

作者：Xiaoshan Li, Shengchao Li, Chengwei Xu, Huan He, Weidong Shao, Shuteng Zhan, Bo Xu · 发表于：Drug Design Development and Therapy · 年份：2025 · DOI：10.2147/dddt.s508264 · 被引用次数：3 · 研究领域：Anesthesia and Sedative Agents、Hemodynamic Monitoring and Therapy、Intraoperative Neuromonitoring and Anesthetic Effects

Objective: This research aimed to quantify the impact of low dose of esketamine on BIS and validate the feasibility of closed-loop TCI system based on the new BIS baseline with low dose of esketamine. Methods: This study consisted of two phases. The first phase was to quantify the impact of a low dose of esketamine (0.2mg kg − 1 bolus, 5μg kg − 1 min − 1 infusion for 30min) on BIS and establish a new BIS baseline for propofol-remifentanil general anesthesia. The second phase was used to validate the feasibility of closed-loop TCI system based on the new BIS baseline. One hundred and eleven patients were randomly and equally assigned to three groups (group A: adjusted group, group N: non-adjusted group and group C: control group). After administering a low dose of esketamine, group A adjusted drug dosage based on new BIS baseline, while group N based on the original BIS baseline of 50, group C adjusted drug doses based on the original baseline of 50 without esketamine. Main outcome was controller performance (% time within± 10units of the BIS setpoint). Secondary outcomes were drug consumption, occurrence of adverse events such as intraoperative awareness, treatment of hemodynamic changes and postoperative recovery quality. Results: In the first phase, after administering a low dose of esketamine, the BIS increased from 49.9± 4.5 to 59.6± 6.0, p < 0.01. In the second phase, the controller performance in group A and N were within the range of high-performance systems, and both ...