闭环麻醉输送系统的多中心评估：一项随机对照试验。

A Multicenter Evaluation of a Closed-Loop Anesthesia Delivery System: A Randomized Controlled Trial.

机构信息

From the *Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India; †Department of Anesthesia, Sir Ganga Ram Hospital, New Delhi, India; ‡Department of Anesthesia, Government Medical College and Hospital, Chandigarh, India; §Department of Anesthesia, Sonam Norbu M Hospital, Leh, Jammu & Kashmir, India; ∥Department of Anesthesia, Dayanand Medical College, Ludhiana, India; ¶Department of Anesthesia, Government Medical College and Hospital, Patiala, Punjab, India; and #National Institute of Electronics and Information Technology (NIELIT), Itanagar, Arunachal Pradesh, India.

出版信息

Anesth Analg. 2016 Jan;122(1):106-14. doi: 10.1213/ANE.0000000000000769.

DOI:10.1213/ANE.0000000000000769

PMID:25902324

Abstract

BACKGROUND

Closed-loop systems for anesthesia delivery have been shown to outperform traditional manual control in different clinical settings. The present trial was aimed at evaluating the feasibility and efficacy of Bispectral Index (BIS)-guided closed-loop anesthesia delivery system (CLADS) in comparison with manual control across multiple centers in India.

METHODS

Adult patients scheduled for major surgical procedures of an expected duration of 1 to 3 hours were randomized across 6 sites into 2 groups: a CLADS group and a manual group. In the manual control group, propofol infusion was titrated manually by the attending anesthesiologist to a BIS of 50 during induction and maintenance. Analgesia was maintained with fentanyl infusion and nitrous oxide in both groups. In the CLADS group, both induction and maintenance of anesthesia were performed automatically using CLADS. The primary outcome measure was the performance of the system as assessed by the percentage of total anesthesia time BIS remained ±10 of target BIS. The secondary outcome measures were a percentage of anesthesia-time heart rate and mean arterial pressure within 25% of the baseline, median absolute performance error, wobble, and global score. Wobble indicates intraindividual variability in the control of BIS, and global score reflects the overall performance; lower values indicate superior performance for both parameters. The performance parameters of the system also were compared among the participating sites.

RESULTS

Two hundred forty-two patients were randomized. BIS was maintained within ±10 of target for significantly longer time in the CLADS group (81.4% ± 8.9 % of anesthesia duration) than in the manual group (55.34% ± 25%, P < 0.0001). The indices that assess performance were significantly better in the CLADS group than the manual group as follows: median absolute performance error was 10 (10, 12) (median [interquartile range]) in the CLADS group versus 18 (14, 24) in the manual group, P < 0.0001; wobble was 9 (8, 10) in CLADS group versus 10 (8, 14) in the manual group, P = 0.0009; and Global score, which reflects overall performance, was 24 (19, 30) in the CLADS group versus 51 (31, 99) in the manual group, P < 0.0001. The percentage of time heart rate was within 25% of the baseline was significantly greater in the CLADS group (heart rate of 95 [87, 99], median [interquartile range], in the CLADS group versus 90 [75, 98] in the manual group P = 0.0031). On comparison of data between the centers, the performance parameters did not differ significantly among the centers in the CLADS group (P = 0.94), but the parameters differed significantly among the centers in the manual group (P < 0.001).

CONCLUSIONS

Our study in a multicenter setting proves the consistently better performance of automated anesthesia drug delivery compared with conventional manual control. This highlights an important advantage of an automated system for delivering standardized anesthesia, thereby overcoming differences in practices among anesthesiologists.

摘要

背景

在不同的临床环境中，已证明用于麻醉输送的闭环系统在性能上优于传统的手动控制。本试验旨在评估在印度多个中心使用脑电双频指数（BIS）指导的闭环麻醉输送系统（CLADS）与手动控制相比的可行性和疗效。

方法

预计手术时间为 1 至 3 小时的成年患者在 6 个地点随机分为 2 组：CLADS 组和手动组。在手动控制组中，通过麻醉师手动滴定丙泊酚输注，使 BIS 在诱导和维持期间达到 50。在两组中均使用芬太尼输注和氧化亚氮维持镇痛。在 CLADS 组中，使用 CLADS 自动进行麻醉的诱导和维持。主要结局指标是系统性能的评估，以 BIS 保持在目标 BIS ± 10 的总麻醉时间百分比来衡量。次要结局指标是心率和平均动脉压在基线的 25%内的麻醉时间百分比、中位数绝对性能误差、摆动和总体评分。摆动表示 BIS 控制的个体内变异性，总体评分反映整体性能；对于这两个参数，较低的值表示性能更好。还比较了系统在参与地点之间的性能参数。

结果

共随机分配了 242 名患者。BIS 在 CLADS 组中保持在目标 ± 10 的时间明显长于手动组（81.4% ± 8.9%的麻醉持续时间），P < 0.0001。评估性能的指标在 CLADS 组明显优于手动组，具体如下：中位数绝对性能误差为 10（10，12）（中位数[四分位数范围]）在 CLADS 组中与 18（14，24）在手动组中，P < 0.0001；摆动为 9（8，10）在 CLADS 组中与 10（8，14）在手动组中，P = 0.0009；总体评分反映整体性能，在 CLADS 组中为 24（19，30），在手动组中为 51（31，99），P < 0.0001。CLADS 组的心率在基线的 25%内的时间百分比明显更大（CLADS 组的心率为 95[87，99]，中位数[四分位数范围]，与手动组的 90[75，98]相比，P = 0.0031）。在对中心间数据的比较中，CLADS 组中心间的性能参数没有显著差异（P = 0.94），但在手动组中心间的参数差异显著（P < 0.001）。