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在低剂量艾氯胺酮存在的情况下基于新脑电图基线的闭环靶控输注可行性:一项随机对照等效性试验
Authors Li X , Li S, Xu C, He H, Shao W, Zhan S, Xu B
Received 24 November 2024
Accepted for publication 4 April 2025
Published 25 April 2025 Volume 2025:19 Pages 3237—3252
DOI http://doi.org/10.2147/DDDT.S508264
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Anastasios Lymperopoulos
Xiaoshan Li,1,2,* Shengchao Li,1,2,* Chanyan Xu,1 Huan He,1 Weidong Shao,1 Shuteng Zhan,1,2 Bo Xu1,2
1Department of Anesthesiology, General Hospital of Southern Theater Command of PLA, Guangzhou, Guangdong, People’s Republic of China; 2The First School of Clinical Medicine, Southern Medical University, Guangzhou, Guangdong, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Bo Xu, Department of Anesthesiology, General Hospital of Southern Theater command of PLA, 111 Liuhua Road, Guangzhou, Guangdong, People’s Republic of China, Email xubo333@hotmail.com
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 were equivalent with control group. Group A showed lower consumption of propofol compared to control group (5.58± 1.12 vs 6.69± 1.36 (mg·kg− 1·h− 1), p< 0.05). There was no difference in adverse events such as intraoperative awareness, recovery assessment and postoperative VAS, PONV and shivering, QoR-15 assessment after adjusting the BIS baseline.
Conclusion: It is feasible to operate the closed-loop TCI system based on the adjusted BIS baseline in the presence of low dose of esketamine.
Keywords: esketamine, new BIS baseline, EEG, closed-loop controlled system, depth of anesthesia