瑞芬太尼对双频指数控制的Bayesian闭环丙泊酚给药系统控制性能的影响

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Influence of Remifentanil on the Control Performance of the Bispectral Index Controlled Bayesian-Based Closed-Loop System for Propofol Administration

背景与目的

本试验是基于模型的临床研究，以双频谱指数（BIS）为控制变量的丙泊酚和瑞芬太尼麻醉诱导和维持过程中，患者个体化闭环(CL)控制系统的建立，以及瑞芬太尼靶向作用部位浓度（CeREMI）对其临床性能的影响。

方  法

在163名患者中，异丙酚使用CL系统给药（BIS 靶点[BISTARGET]在40~50之间）。根据临床需要选择2~7.5ng/mL作为初始CeREMI靶点。诱导过程中的性能参数是首次达到目标BIS所需时间，诱导后达到最大药物效应所需的时间（TPEAK，BIS）和此时对应的BIS，以及诱导结束时恢复目标BIS所需时间。麻醉维持期间的性能定义为：目标BIS±10的病例时间与目标BIS之间的百分比，观察值与目标BIS值之间的性能误差（PE）及其派生出的中位数PE (MDPE)，作为控制偏差的衡量，中位数绝对PE（MDAPE）作为控制不精确性的度量，散度作为测量BIS值相对于目标BIS值的时间相关趋势的度量，摆动作为预测误差中受试者内部变化的一种衡量。次要结果是CL控制期间患者的血流动力学稳定性。

结 果  

应用的CL系统在临床可接受的范围内诱导和维持麻醉。所有研究参与者的病例时间[均值(标准差[SD])与BIS±10的百分比为82%（14%）。MDPE和MDAPE的平均值（SD）分别为-6.6%（5.5%）和11.2%（5.5%）。研究发现了负发散度[-0.001（0.004）]和可接受的摆动[9.7%（4.0%）]。系统PE与CeREMI的相关性较低，仅受CeREMI<2.8ng/mL的影响。血流动力学稳定在临床可接受范围内。

结 论

在麻醉诱导和维持期间，用于异丙酚给药的CL系统在2.8~7.5ng/mL的CeREMI范围内具有良好效果。尚无证据表明CeREMI与CL性能之间有很强的相关性。这项研究还表明，当CeREMI低于2.8ng/mL时，预防异丙酚麻醉时的觉醒可能更具挑战性。

原始文献来源及摘要

Martine Neckebroek, Jan-Willem, Boldingh, et al. Influence of Remifentanil on the Control Performance of the Bispectral Index Controlled Bayesian-Based Closed-Loop System for Propofol Administration.[J].Anesth Analg 2020;130:1661–9.

Abstract

BACKGROUND: This study investigated the clinical performance of a model-based, patient-individualized closed-loop (CL) control system for propofol administration using the bispectral index (BIS) as a controlled variable during the induction and maintenance of anesthesia with propofol and remifentanil and studied the influence of the targeted effect-site concentration of remifentanil (CeREMI) on its clinical performance.

METHODS: In 163 patients, propofol was administered using a CL system (BIS target [BISTARGET] between 40 and 50). Initial CeREMI targets between 2 and 7.5 ng/mL were selected as deemed clinically required. Performance parameters during induction were the time required to initially cross the target BIS, the time required to reach the maximal drug effect after induction (TPEAK, BIS) and the corresponding BIS at this moment, and the time required to regain the target BIS at the end of induction. Performance during maintenance was defined as the percentage of case time with target BIS ± 10 from target and the amount of performance error (PE) between the observed and target BIS values and its derived median PE (MDPE) as a measure of control bias, median absolute PE (MDAPE) as a measure of control inaccuracy, divergence as a measure of the time-related trend of the measured BIS values relative to the target BIS values, and wobble as a measure of intrasubject variability in prediction error. The secondary end point was the hemodynamic stability of the patient during CL control.

RESULTS: The applied CL system induced and maintained anesthesia within clinically accepted ranges. The percentage of case time [mean (standard deviation [SD]) across all study participants] with BIS ± 10 from the target was 82% (14%). The mean (SD) population MDPE and MDAPE were −6.6% (5.5%) and 11.2% (5.5%), respectively. A negative divergence [−0.001 (0.004)] and acceptable wobble [9.7% (4.0%)] were found. The correlation between the system PE and CeREMI was low and only influenced by a CeREMI <2.8 ng/mL. Hemodynamic stability stayed within the clinically acceptable range.

CONCLUSIONS: The applied CL system for propofol administration has an acceptable performance in the CeREMI range of 2.8–7.5 ng/mL during the induction and maintenance of anesthesia. There was no evidence of a strong association between CeREM and the CL performance. This study also shows that when the CeREMI is <2.8 ng/mL, it might be more challenging to prevent arousal during propofol anesthesia.

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