低剂量艾氯胺酮存在下基于新脑电图基线的闭环TCI的可行性：一项随机对照等效试验。

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2025-04-25 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S508264

Xiaoshan Li, Shengchao Li, Chanyan Xu, Huan He, Weidong Shao, Shuteng Zhan, Bo Xu

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引用次数: 0

摘要

目的：本研究旨在量化低剂量艾氯胺酮对BIS的影响，验证基于低剂量艾氯胺酮新BIS基线的闭环TCI系统的可行性。方法：本研究分为两个阶段。第一阶段是量化低剂量艾氯胺酮（0.2mg kg-1, 5μg kg-1 min-1输注30min）对BIS的影响，并建立异丙酚-瑞芬太尼全身麻醉下新的BIS基线。第二阶段用于验证基于新BIS基线的闭环TCI系统的可行性。111例患者随机平均分为3组（A组：调整组，N组：未调整组，C组：对照组）。在给予低剂量艾氯胺酮后，a组根据新的BIS基线调整用药剂量，N组根据原BIS基线50调整用药剂量，C组根据未使用艾氯胺酮的原基线50调整用药剂量。主要结果为控制器性能（在BIS设定值±10个单位内的%时间）。次要结果为药物消耗、术中意识等不良事件的发生、血流动力学变化的处理和术后恢复质量。结果：一期低剂量艾氯胺酮给药后，BIS由49.9±4.5上升至59.6±6.0 (p-1·h-1)，结论：在低剂量艾氯胺酮存在下，基于调整BIS基线的闭环TCI系统运行是可行的。

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

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.

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.