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瑞芬太尼和喉罩全身麻醉时的出现时间和气道反应:一项多中心随机对照试验。

Emergence times and airway reactions during general anaesthesia with remifentanil and a laryngeal mask airway: A multicentre randomised controlled trial.

机构信息

From the Department of Anaesthesiology, Medical Faculty, RWTH Aachen University, Aachen (AK, RR, MC), Department of Anaesthesiology and Intensive Care Medicine, Klinikum am Steinenberg, Reutlingen (FP, CR, HH), Department of Medical Informatics, Medical Faculty, RWTH Aachen University, Aachen (APK), Department of Anaesthesiology and Intensive Care Medicine, Martha-Maria Hospital, Halle (Saale) (HF, VO) and Department of Anaesthesiology, University Hospital Ulm, Ulm, Germany (GF).

出版信息

Eur J Anaesthesiol. 2018 Aug;35(8):588-597. doi: 10.1097/EJA.0000000000000852.

DOI:10.1097/EJA.0000000000000852
PMID:29916859
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6072370/
Abstract

BACKGROUND

Avoidance of airway complications and rapid emergence from anaesthesia are indispensable for the use of a laryngeal mask airway (LMA). Evidence from adequately powered randomised studies with a low risk of bias for the optimal anaesthetic in this context is limited.

OBJECTIVE

We tested the hypothesis that when using remifentanil-based intra-operative analgesia, desflurane would be the most suitable anaesthetic: with noninferiority in the occurrence of upper airway complications and superiority in emergence times compared with sevoflurane or propofol.

DESIGN

A randomised, multicentre, partially double-blinded, three-arm, parallel-group study.

SETTING

Two university and two regional German hospitals, from February to October 2015.

PATIENTS

A total of 352 patients (age 18 to 75 years, ASA physical status I to III, BMI less than 35 kg m and fluent in German) were enrolled in this study. All surgery was elective with a duration of 0.5 to 2 h, and general anaesthesia with a LMA was feasible.

INTERVENTION

The patients were randomised to receive desflurane, sevoflurane or propofol anaesthesia.

MAIN OUTCOME MEASURES

This study was powered for the primary outcome 'time to state date of birth' and the secondary outcome 'intra-operative cough'. Time to emergence from anaesthesia and the incidence of upper airway complications were assessed on the day of surgery.

RESULTS

The primary outcome was analysed for 343 patients: desflurane (n=114), sevoflurane (n=111) and propofol (n=118). The desflurane group had the fastest emergence. The mean (± SD) times to state the date of birth following desflurane, sevoflurane and propofol were 8.1 ± 3.6, 10.1 ± 4.0 and 9.8 ± 5.1 min, respectively (P < 0.01). There was no difference in upper airway complications (cough and laryngospasm) across the groups, but these complications were less frequent than in previous studies.

CONCLUSION

When using a remifentanil infusion for intra-operative analgesia in association with a LMA, desflurane was associated with a significantly faster emergence and noninferiority in the incidence of intra-operative cough than either sevoflurane or Propofol.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02322502; EudraCT identifier: 2014-003810-96.

摘要

背景

为了避免气道并发症并使患者快速从麻醉中苏醒,使用喉罩(LMA)时需要避免出现麻醉相关并发症。但目前仅有一些小样本随机对照研究,且这些研究存在低质量偏倚风险,因此目前有关该问题的最佳麻醉证据十分有限。

目的

本研究旨在验证假设,即在使用瑞芬太尼进行术中镇痛时,地氟醚是否为最适合的麻醉药物:与七氟醚或丙泊酚相比,地氟醚在发生上呼吸道并发症方面不劣于另两种药物,且患者苏醒时间更快。

设计

这是一项随机、多中心、部分双盲、三臂、平行组研究。

地点

该研究在德国两所大学附属医院和两所地区医院进行,时间为 2015 年 2 月至 10 月。

患者

共纳入 352 名年龄在 18 至 75 岁之间、ASA 身体状况 I 至 III 级、BMI 小于 35kg/m²、能流利使用德语的患者。所有手术均为择期手术,持续时间 0.5 至 2 小时,可行全身麻醉联合 LMA。

干预措施

患者被随机分为地氟醚组、七氟醚组或丙泊酚组。

主要观察指标

本研究主要针对“说出出生日期”这一主要结局和“术中咳嗽”这一次要结局进行分析。术后当天评估患者的苏醒时间和上呼吸道并发症发生率。

结果

343 名患者参与了主要结局的分析:地氟醚组(n=114)、七氟醚组(n=111)和丙泊酚组(n=118)。地氟醚组患者苏醒最快。地氟醚组、七氟醚组和丙泊酚组患者说出出生日期的平均(±SD)时间分别为 8.1±3.6、10.1±4.0 和 9.8±5.1 分钟(P<0.01)。三组患者的上呼吸道并发症(咳嗽和喉痉挛)发生率无差异,但均低于既往研究。

结论

在使用瑞芬太尼输注进行术中镇痛并联合 LMA 时,与七氟醚或丙泊酚相比,地氟醚可使患者更快苏醒,且术中咳嗽发生率无差异。

试验注册

ClinicalTrials.gov 标识符:NCT02322502;EudraCT 标识符:2014-003810-96。

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