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右美托咪定与苯二氮䓬类药物用于老年患者术中镇静的比较:一项随机临床试验。

Comparison of dexmedetomidine and benzodiazepine for intraoperative sedation in elderly patients: a randomized clinical trial.

机构信息

Department of Anesthesiology, Hospital Servidor Público Estadual-Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, Brazil

Division of Anesthesiology, Faculty of Medicine of the University of São Paulo, São Paulo, Brazil.

出版信息

Reg Anesth Pain Med. 2019 Mar;44(3):319-324. doi: 10.1136/rapm-2018-100120. Epub 2019 Feb 3.

Abstract

BACKGROUND AND OBJECTIVES

Elderly individuals have a greater sensitivity to sedation, and the most commonly used drugs for sedation are benzodiazepines, which exhibit some complication. Therefore, this study aimed to compare the use of dexmedetomidine and midazolam regarding proper sedation and postoperative complications in elderly individuals who require intraoperative sedation.

METHODS

This study was a parallel-randomized clinical trial, which included 120 patients aged >70 years undergoing regional anesthesia and sedation. The exclusion criteria consisted of bradycardia, heart failure, respiratory failure, a Glasgow Coma Scale ≤14, liver failure and refusal to participate. Patients were divided into two groups: the first group received midazolam (MDZ), while the second group received dexmedetomidine (DEX). The doses were titrated to achieve an intraoperative Richmond Agitation-Sedation Scale (RASS) score between -3 and -1. Incidences of complications were recorded.

RESULTS

During a 120 min follow-up, the depth of sedation (RASS score) revealed variations less often in the DEX group (p=0.002). Patients in the DEX group (n=67) had lower rates of intraoperative complications (19.4% vs 73.6%, p<0.001). Intraoperatively, the incidence rates of psychomotor agitation (15.1% vs 1.5%, p=0.005), arterial hypotension (28.3% vs 3.0%, p<0.001) and respiratory depression (73.6% vs 0%, p<0.001) were higher in the MDZ group (n=53). During postanesthesia care, the incidence rates of shivering (p<0.001), residual sedation (p=0.04) and use of supplemental oxygen (p<0.001) were significantly lower in the DEX group.

CONCLUSIONS

The use of DEX for sedation during surgery provides better control over the depth of sedation and produces fewer complications in elderly individuals.

TRIAL REGISTRATION NUMBER

NCT02878837.

摘要

背景与目的

老年人对镇静的敏感性更高,最常使用的镇静药物是苯二氮䓬类药物,但此类药物存在一些并发症。因此,本研究旨在比较右美托咪定和咪达唑仑在需要术中镇静的老年患者中的镇静效果和术后并发症。

方法

这是一项平行随机临床试验,纳入了 120 名年龄>70 岁、接受区域麻醉和镇静的患者。排除标准包括心动过缓、心力衰竭、呼吸衰竭、格拉斯哥昏迷量表评分≤14、肝衰竭和拒绝参与。患者被分为两组:第一组接受咪达唑仑(MDZ),第二组接受右美托咪定(DEX)。滴定剂量以达到术中 Richmond 激动-镇静量表(RASS)评分-3 至-1。记录并发症的发生率。

结果

在 120 分钟的随访中,DEX 组镇静深度(RASS 评分)变化较少(p=0.002)。DEX 组(n=67)患者术中并发症发生率较低(19.4% vs 73.6%,p<0.001)。术中,精神运动性激动发生率(15.1% vs 1.5%,p=0.005)、动脉低血压发生率(28.3% vs 3.0%,p<0.001)和呼吸抑制发生率(73.6% vs 0%,p<0.001)在 MDZ 组(n=53)中更高。在麻醉后护理期间,DEX 组寒战发生率(p<0.001)、残留镇静发生率(p=0.04)和补充氧气使用率(p<0.001)均显著降低。

结论

DEX 用于老年患者手术中的镇静可更好地控制镇静深度,并减少并发症。

试验注册号

NCT02878837。

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