闭环与手动靶控输注丙泊酚和瑞芬太尼用于择期非心脏大手术患者术后神经认知障碍：随机对照术后认知功能障碍-脑电图引导麻醉管理试验。

Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial.

机构信息

From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.

Department of Neurology, University Hospital of Besancon, and EA 481 Neuroscience, IFR 133, University of Bourgogne Franche-Comte, Besancon, France.

出版信息

Anesth Analg. 2021 Oct 1;133(4):837-847. doi: 10.1213/ANE.0000000000005278.

DOI:10.1213/ANE.0000000000005278

PMID:33181558

Abstract

BACKGROUND

The aim of the study was to investigate whether closed-loop compared to manual bispectral index (BIS)-guided target-controlled infusion of propofol and remifentanil could decrease the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery.

METHODS

Patients aged >50 admitted for elective major noncardiac surgery were included in a single-blind randomized (ratio 2:1) trial. The anesthetic protocol was allocated by randomization into either closed-loop or manual BIS-guided propofol and remifentanil titration. The BIS target range was 40-60. All patients had cognitive assessment the day before surgery and within 72 hours after surgery using a battery of neuropsychological tests. The primary outcome was the rate of postoperative neurocognitive disorders. Postoperative neurocognitive disorders were defined as a decrease >20% from baseline on at least 3 scores. Intergroup comparison of the primary outcome was performed using the χ2 test.

RESULTS

A total of 143 and 61 patients were included in the closed-loop and manual groups, respectively (age: 66 [8] vs 66 [9] years). The primary outcome was observed in 18 (13%) and 10 (16%) patients of the closed-loop and manual groups, respectively (relative risk [95% confidence interval {CI}], 0.77 [0.38-1.57], P = .47). Intraoperative propofol consumption was lower (4.7 [1.4] vs 5.7 [1.4] mg·kg-1·h-1, mean difference [MD] [95% CI], -0.73 [-0.98 to -0.48], P < .0001) and the proportion of time within the BIS target range higher (84 [77-89] vs 74 [54-81]%, MD [95% CI], 0.94 [0.67-1.21], P < .0001) in the closed-loop group.

CONCLUSIONS

Closed-loop compared to manual BIS-guided total intravenous anesthesia provided a significant reduction in episodes of an excessive depth of anesthesia while decreasing intraoperative propofol requirement but no evidence for a reduction of the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery was observed.

摘要

背景

本研究旨在探讨与手动双频谱指数（BIS）指导的丙泊酚和瑞芬太尼靶控输注相比，闭环是否可以降低择期非心脏大手术患者术后神经认知障碍的发生率。

方法

纳入年龄>50 岁、择期行非心脏大手术的患者，进行单盲随机（比例 2:1）试验。麻醉方案通过随机分配进入闭环或手动 BIS 指导的丙泊酚和瑞芬太尼滴定。BIS 目标范围为 40-60。所有患者在术前一天和术后 72 小时内使用一系列神经心理学测试进行认知评估。主要结局是术后神经认知障碍的发生率。术后神经认知障碍定义为至少 3 项评分中有 20%以上的下降。使用卡方检验比较两组间的主要结局。

结果

闭环组和手动组分别纳入 143 例和 61 例患者（年龄：66[8]岁 vs 66[9]岁）。闭环组和手动组分别有 18 例（13%）和 10 例（16%）患者出现主要结局（相对风险[95%置信区间{CI}]，0.77[0.38-1.57]，P=0.47）。术中丙泊酚消耗较低（4.7[1.4]mg·kg-1·h-1 vs 5.7[1.4]mg·kg-1·h-1，平均差值[MD] [95%CI]，-0.73[-0.98 至-0.48]，P<0.0001），BIS 目标范围内的时间比例较高（84[77-89]% vs 74[54-81]%，MD [95%CI]，0.94[0.67-1.21]，P<0.0001）在闭环组。