比较相位滞后熵和双谱指数在右美托咪定镇静下监测镇静深度的性能：一项前瞻性、观察性、非劣效性试验。

Comparison of the performance of phase lag entropy and bispectral index for monitoring the depth of sedation under dexmedetomidine sedation: A prospective, observational, and non-inferiority trial.

机构信息

Department of Anaesthesiology and Pain Medicine, Inje University Busan Paik Hospital, Busan, Republic of Korea.

Department of Anaesthesiology and Pain Medicine, Inje University Haeundae Paik Hospital, Busan, Republic of Korea.

出版信息

J Clin Anesth. 2022 Nov;82:110945. doi: 10.1016/j.jclinane.2022.110945. Epub 2022 Aug 25.

DOI:10.1016/j.jclinane.2022.110945

PMID:36029705

Abstract

STUDY OBJECTIVE

Although the performance of phase lag entropy (PLE), a new depth-of-sedation monitor based on the diversity of temporal patterns in the phase relationships in electroencephalogram (EEG) data, during propofol sedation has been proven through several studies, since different sedatives have different effects on EEG, we aimed to evaluate the performance of the PLE in comparison with the bispectral index (BIS) during dexmedetomidine sedation.

DESIGN

A prospective, observational, and non-inferiority trial.

SETTING

Tertiary university hospital operating room.

PATIENTS

Forty-two patients aged 20-80 years who were scheduled to undergo elective surgery under spinal anesthesia and had American Society of Anesthesiologists (ASA) physical status I to III were enrolled in this study.

INTERVENTIONS

Dexmedetomidine was administered with a loading dose of 0.5-1 μg/kg for 10 min, followed by a maintenance dose of 0.3-0.6 μg/kg/h.

MEASUREMENTS

The depth of sedation was assessed using the modified observer's assessment of alertness/sedation (MOAA/S) scale; the data for PLE and BIS were collected; and vital signs, including blood pressure, heart rate, EKG, and pulse oximetry, were evaluated.

MAIN RESULTS

215,082 data points for the MOAA/S score and PLE and BIS values were analyzed. The baseline variabilities of PLE and BIS were 4.53% and 7.02%, respectively. The Spearman correlation coefficients of the MOAA/S score with PLE and BIS were 0.599 and 0.566, respectively. The prediction probabilities of the MOAA/S score with PLE and BIS were 0.647 and 0.636, respectively. When the MOAA/S score was 3 points, the mean (SD) values of PLE and BIS were 68.35 (15.68) and 75.85 (9.81), respectively, However, the mean (SD) values of PLE and BIS for an MOAA/S score of 1 point were 56.08 (12.49) and 68.29 (12.65), respectively.

CONCLUSIONS

PLE shows potential as a hypnotic depth indicator during dexmedetomidine sedation, and its performance was not inferior to that of BIS.

摘要

研究目的

尽管相位滞后熵（PLE）作为一种新的镇静深度监测仪，基于脑电图（EEG）数据中相位关系时间模式的多样性，已经在几项研究中得到了证明，但由于不同的镇静剂对 EEG 有不同的影响，我们旨在评估 PLE 在右美托咪定镇静期间与双频谱指数（BIS）的性能比较。

设计

前瞻性、观察性、非劣效性试验。

设置

三级大学医院手术室。

患者

42 名年龄在 20-80 岁之间的患者，计划在脊髓麻醉下接受择期手术，美国麻醉医师协会（ASA）身体状况 I 至 III 级。

干预措施

右美托咪定以 0.5-1μg/kg 的负荷剂量输注 10 分钟，然后以 0.3-0.6μg/kg/h 的维持剂量输注。

测量

使用改良的观察者警觉/镇静评分（MOAA/S）量表评估镇静深度；收集 PLE 和 BIS 数据；评估生命体征，包括血压、心率、心电图和脉搏血氧饱和度。

主要结果

分析了 MOAA/S 评分和 PLE、BIS 值的 215082 个数据点。PLE 和 BIS 的基线变异性分别为 4.53%和 7.02%。MOAA/S 评分与 PLE 和 BIS 的 Spearman 相关系数分别为 0.599 和 0.566。MOAA/S 评分与 PLE 和 BIS 的预测概率分别为 0.647 和 0.636。当 MOAA/S 评分为 3 分时，PLE 和 BIS 的平均值（标准差）分别为 68.35（15.68）和 75.85（9.81），然而，MOAA/S 评分为 1 分时，PLE 和 BIS 的平均值（标准差）分别为 56.08（12.49）和 68.29（12.65）。