内镜食管手术中使用右美托咪定或丙泊酚镇静的满意度与安全性：一项随机对照试验。

Satisfaction and safety using dexmedetomidine or propofol sedation during endoscopic oesophageal procedures: A randomised controlled trial.

作者信息

Eberl Susanne, Preckel Benedikt, Bergman Jacques J, van Dieren Susan, Hollmann Markus W

机构信息

From the Department of Anaesthesiology (SE, BP, MWH), Department of Gastroenterology & Hepatology (JJB), and Clinical Research Unit, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands (SVD).

出版信息

Eur J Anaesthesiol. 2016 Sep;33(9):631-7. doi: 10.1097/EJA.0000000000000438.

DOI:10.1097/EJA.0000000000000438

PMID:26950082

Abstract

BACKGROUND

Dexmedetomidine possesses anxiolytic and hypnotic properties without respiratory side-effects, making it theoretically an ideal sedative agent for endoscopic procedures.

OBJECTIVE

We aimed to compare satisfaction and safety among outpatients receiving sedation with dexmedetomidine or propofol for endoscopic oesophageal procedures.

DESIGN

A randomised controlled study.

SETTING

Endoscopic intervention suite at the Academic Medical Centre in Amsterdam, Netherlands.

PARTICIPANTS

Patients aged at least 18 years, and American Society of Anesthesiologists' physical status 1 to 3.

INTERVENTION

Total 63 patients were randomised to receive either dexmedetomidine (D) or propofol (P). Pain was treated with alfentanil in both groups.

MAIN OUTCOME MEASURES

The primary outcomes were patients' and endoscopists' satisfaction levels measured by validated questionnaires (1 = very dissatisfied; 7 = highly satisfied). A secondary outcome was safety, determined by blood pressure, heart rate and oxygen saturation during and after the procedure, and respiratory rate and noninvasive cardiac output during the procedure.

RESULTS

Satisfaction of patients [median (IQR); group D, 5.0 (3.75 to 5.75) vs. group P, 6.25 (5.3 to 6.5)] and satisfaction of gastroenterologists [group D, 5.0 (4.4 to 5.8) vs. group P, 6.0 (5.4 to 6.0)] were lower in group D (both P < 0.001). More patients in group D would not recommend this form of sedation to one of their friends (group D, 15 of 32 vs. group P, 1 of 31; P < 0.001). Total 30 min after the procedure, heart rate [group D, 60 bpm (52 to 69) vs. group P, 70 bpm (60 to 81), P = 0.031] and SBP group D, 112 mmHg (92 to 132) vs. group P, 120 mmHg (108 to 132); P = 0.013] were significantly lower after dexmedetomidine sedation. There were no other differences in safety between groups.

CONCLUSION

Compared with propofol, sedation with dexmedetomidine resulted in less satisfaction, and caused prolonged haemodynamic depression after endoscopic oesophageal procedures.

TRIAL REGISTRATION

ISRCTN Register (ISRCTN 68599804).

摘要

背景

右美托咪定具有抗焦虑和催眠特性，且无呼吸副作用，理论上是内镜手术理想的镇静剂。

目的

我们旨在比较接受右美托咪定或丙泊酚镇静的门诊患者在内镜食管手术中的满意度和安全性。

设计

一项随机对照研究。

地点

荷兰阿姆斯特丹学术医疗中心的内镜干预套房。

参与者

年龄至少18岁，美国麻醉医师协会身体状况1至3级的患者。

干预措施

总共63例患者被随机分配接受右美托咪定（D组）或丙泊酚（P组）。两组均用阿芬太尼治疗疼痛。

主要观察指标

主要结局是通过有效问卷测量的患者和内镜医师的满意度水平（1 =非常不满意；7 =高度满意）。次要结局是安全性，通过手术期间及术后的血压、心率和血氧饱和度以及手术期间的呼吸频率和无创心输出量来确定。

结果

D组患者的满意度[中位数（四分位间距）；D组，5.0（3.75至5.75）对P组，6.25（5.3至6.5）]和胃肠病学家的满意度[D组，5.0（4.4至5.8）对P组，6.0（5.4至6.0）]低于P组（P均<0.001）。D组中更多患者不会向朋友推荐这种镇静方式（D组，32例中的15例对P组，31例中的1例；P<0.001）。术后30分钟时，右美托咪定镇静后心率[D组，60次/分（52至69）对P组，70次/分（60至81），P = 0.031]和收缩压[D组，112 mmHg（92至132）对P组，120 mmHg（108至132）；P = 0.013]显著更低。两组之间在安全性方面无其他差异。