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静脉注射对乙酰氨基酚与静脉注射芬太尼用于结肠镜检查中丙泊酚深度镇静的临床疗效比较:一项随机对照试验

Clinical Efficacy Between Intravenous Paracetamol and Intravenous Fentanyl for Propofol Deep Sedation in Colonoscopy: A Randomized Controlled Trial.

作者信息

Thiparporn Thanitthi, Supan Wilaiporn, Amornyotin Somchai

机构信息

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Drug Des Devel Ther. 2025 Jan 23;19:471-478. doi: 10.2147/DDDT.S479084. eCollection 2025.

DOI:10.2147/DDDT.S479084
PMID:39872636
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11771515/
Abstract

INTRODUCTION

Sedation practices for colonoscopy indeed vary widely around the globe. Due to a lack of data on intravenous paracetamol, we aimed to investigate the clinical efficacy of intravenous paracetamol compared to intravenous fentanyl under propofol deep sedation for colonoscopy.

METHODS

A total of 225 patients who underwent colonoscopy at Siriraj Hospital were randomly assigned to two groups. All patients underwent deep sedation with propofol and received intravenous (iv) paracetamol (group P, n = 113) or iv fentanyl (group F, n = 112). All patients received a premedication of 0.02-0.03 mg/kg of midazolam intravenously. Fifteen to thirty minutes before the procedure, patients in group P were administered 1000 mg of iv paracetamol, while those in group F received 0.001 mg/kg of iv fentanyl. All patients were oxygenated with 100% O via a nasal cannula, and deep sedated with titrated intravenous propofol. The primary outcome measure was the success rate of colonoscopy. The colonoscope reaching the ileocecal valve was an important marker for a successful colonoscopy. Secondary outcome measures included endoscopist and patient satisfaction, patient tolerance, ease of the procedure, and sedation-related complications during and immediately after the procedure.

RESULTS

All colonoscopies were successfully completed. There were no significant differences in patient characteristics, duration of the procedure, endoscopist and patient satisfaction, patient tolerance, or ease of the procedure between the two groups. However, group F experienced significantly higher rates of upper airway obstruction and oxygen desaturation during the procedure compared to group P. No serious complications were observed in either group.

CONCLUSION

Intravenous paracetamol with propofol deep sedation in adult patients is non-inferior to intravenous fentanyl for successful colonoscopy completion. Sedation-related complications were relatively lower in the propofol deep sedation with iv paracetamol group compared to the propofol deep sedation with iv fentanyl group.

REGISTRATION

This trial was registered with the Thai Clinical Trial Registry (TCTR 20190321002).

摘要

引言

全球范围内结肠镜检查的镇静方法确实存在很大差异。由于缺乏静脉注射对乙酰氨基酚的数据,我们旨在研究在结肠镜检查丙泊酚深度镇静下,静脉注射对乙酰氨基酚与静脉注射芬太尼相比的临床疗效。

方法

共有225例在诗里拉吉医院接受结肠镜检查的患者被随机分为两组。所有患者均接受丙泊酚深度镇静,并接受静脉注射对乙酰氨基酚(P组,n = 113)或静脉注射芬太尼(F组,n = 112)。所有患者均静脉注射0.02 - 0.03 mg/kg的咪达唑仑进行术前用药。在手术前15至30分钟,P组患者静脉注射1000 mg对乙酰氨基酚,而F组患者静脉注射0.001 mg/kg芬太尼。所有患者均通过鼻导管吸入100%氧气,并通过静脉注射丙泊酚进行深度镇静。主要观察指标是结肠镜检查的成功率。结肠镜到达回盲瓣是结肠镜检查成功的重要标志。次要观察指标包括内镜医师和患者满意度、患者耐受性、操作的难易程度以及手术期间和手术后立即出现的与镇静相关的并发症。

结果

所有结肠镜检查均成功完成。两组患者的特征、手术持续时间、内镜医师和患者满意度、患者耐受性或操作难易程度均无显著差异。然而,与P组相比,F组在手术期间上呼吸道梗阻和氧饱和度下降的发生率显著更高。两组均未观察到严重并发症。

结论

在成年患者中,静脉注射对乙酰氨基酚联合丙泊酚深度镇静在成功完成结肠镜检查方面不劣于静脉注射芬太尼。与静脉注射芬太尼联合丙泊酚深度镇静组相比,静脉注射对乙酰氨基酚联合丙泊酚深度镇静组与镇静相关的并发症相对较少。

注册情况

本试验已在泰国临床试验注册中心注册(TCTR 20190321002)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f9b/11771515/29f1e77528b4/DDDT-19-471-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f9b/11771515/29f1e77528b4/DDDT-19-471-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f9b/11771515/29f1e77528b4/DDDT-19-471-g0001.jpg

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