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布托啡诺和舒芬太尼用于胃肠镜检查镇静时 ED95 的比较:一项随机对照试验。

Comparison of ED95 of Butorphanol and Sufentanil for gastrointestinal endoscopy sedation: a randomized controlled trial.

机构信息

Department of Anesthesiology, the First Affiliated Hospital, Wenzhou Medical University, Shangcai village, Nanbaixiang town, Ouhai District, Wenzhou City, 325000, Zhejiang Province, China.

出版信息

BMC Anesthesiol. 2020 May 2;20(1):101. doi: 10.1186/s12871-020-01027-5.

DOI:10.1186/s12871-020-01027-5
PMID:32359348
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7195772/
Abstract

BACKGROUND

Butorphanol, a synthetic opioid partial agonist analgesic, has been widely used to control perioperative pain. However, the ideal dose and availability of butorphanol for gastrointestinal (GI) endoscopy are not well known. The aim of this study was to evaluated the 95% effective dose (ED) of butorphanol and sufentanil in GI endoscopy and compared their clinical efficacy, especially regarding the recovery time.

METHODS

The study was divided into two parts. For the first part, voluntary patients who needed GI endoscopy anesthesia were recruited to measure the ED of butorphanol and sufentanil needed to achieve successful sedation before GI endoscopy using the sequential method (the Dixon up-and-down method). The second part was a double-blind, randomized study. Two hundred cases of painless GI endoscopy patients were randomly divided into two groups (n = 100), including group B (butorphanol at the ED dose) and group S (sufentanil at the ED dose). Propofol was infused intravenously as the sedative in both groups. The recovery time, visual analogue scale (VAS) score, hand grip strength, fatigue severity scores, incidence of nausea and vomiting, and incidence of dizziness were recorded.

RESULTS

The ED of butorphanol for painless GI endoscopy was 9.07 μg/kg (95% confidence interval: 7.81-19.66 μg/kg). The ED of sufentanil was 0.1 μg/kg (95% CI, 0.079-0.422 μg/kg). Both butorphanol and sufentanil provided a good analgesic effect for GI endoscopy. However, the recovery time for butorphanol was significantly shorter than that for sufentanil (P < 0.05, group B vs. group S:21.26 ± 7.70 vs. 24.03 ± 7.80 min).

CONCLUSIONS

Butorphanol at 9.07 μg/kg was more effective than sufentanil for GI endoscopy sedation and notably reduced the recovery time.

TRIAL REGISTRATION

Chinese Clinical Trail Registry (Registration number # ChiCTR1900022780; Date of Registration on April 25rd, 2019).

摘要

背景

布托啡诺是一种合成阿片类部分激动剂镇痛药,已广泛用于控制围手术期疼痛。然而,用于胃肠镜检查的布托啡诺的理想剂量和可用性尚不清楚。本研究旨在评估布托啡诺和舒芬太尼用于胃肠镜检查的 95%有效剂量(ED),并比较它们的临床疗效,特别是在恢复时间方面。

方法

本研究分为两部分。第一部分,招募需要胃肠镜检查麻醉的自愿患者,使用序贯法(Dixon 上下法)测量布托啡诺和舒芬太尼在胃肠镜检查前达到成功镇静所需的 ED。第二部分为双盲、随机研究。将 200 例无痛胃肠镜检查患者随机分为两组(n=100),包括 B 组(布托啡诺 ED 剂量)和 S 组(舒芬太尼 ED 剂量)。两组均静脉注射丙泊酚作为镇静剂。记录恢复时间、视觉模拟评分(VAS)评分、手握力、疲劳严重程度评分、恶心呕吐发生率和头晕发生率。

结果

布托啡诺用于无痛胃肠镜检查的 ED 为 9.07μg/kg(95%置信区间:7.81-19.66μg/kg)。舒芬太尼的 ED 为 0.1μg/kg(95%CI,0.079-0.422μg/kg)。布托啡诺和舒芬太尼均为胃肠镜检查提供了良好的镇痛效果。然而,布托啡诺的恢复时间明显短于舒芬太尼(P<0.05,B 组与 S 组:21.26±7.70 vs. 24.03±7.80min)。

结论

布托啡诺 9.07μg/kg 用于胃肠镜检查镇静效果优于舒芬太尼,明显缩短恢复时间。

试验注册

中国临床试验注册中心(注册号:ChiCTR1900022780;注册日期:2019 年 4 月 25 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39c9/7195772/344fb2d0ece8/12871_2020_1027_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39c9/7195772/eec9ad5113fa/12871_2020_1027_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39c9/7195772/344fb2d0ece8/12871_2020_1027_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39c9/7195772/eec9ad5113fa/12871_2020_1027_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39c9/7195772/344fb2d0ece8/12871_2020_1027_Fig2_HTML.jpg

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