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单次静脉输注阿芬太尼或舒芬太尼联合丙泊酚靶控输注用于日间宫腔镜检查的比较:一项随机临床试验。

Comparison of a single intravenous infusion of alfentanil or sufentanil combined with target-controlled infusion of propofol for daytime hysteroscopy: a randomized clinical trial.

作者信息

Lei Xiaofeng, Zhang Tinghuan, Huang Xuezhu

机构信息

Department of Anesthesiology, Women and Children's Hospital of Chongqing Medical University (Chongqing Health Center for Women and Children), Chongqing, China.

Department of Anesthesiology, Chongqing Rongchang Health Center for Women and Children, Chongqing, China.

出版信息

Ther Adv Drug Saf. 2024 Oct 31;15:20420986241292231. doi: 10.1177/20420986241292231. eCollection 2024.

Abstract

BACKGROUND

The administration of either alfentanil or sufentanil as a single injection, combined with target-controlled infusion (TCI) of propofol, represents a frequently employed anesthetic regimen for daytime hysteroscopy.

OBJECTIVES

This study was designed to evaluate and compare the safety and efficacy of alfentanil and sufentanil in the context of daytime hysteroscopy.

DESIGN

A total of 160 patients, scheduled for daytime hysteroscopy, were randomly allocated into two groups: Group A and Group S respectively received alfentanil 10 μg/kg or sufentanil 0.15 μg/kg as a single intravenous injection. Both groups were given propofol with TCI for sedation.

METHODS

Monitoring of vital signs was conducted from pre-anesthesia through to 2 h postoperatively. The primary outcome measured was hypoxemia, defined as SpO levels below 92% for a duration of 30 s, which necessitated manual positive pressure ventilation. Secondary outcomes included various perioperative complications, such as postoperative nausea and vomiting (PONV) occurring 2 h after surgery, as well as hemodynamic indicators, NRS scores for pain, and other anesthesia-related data. This comprehensive dataset was meticulously documented and subsequently analyzed for comparative purposes.

RESULTS

The analyses revealed that Group A had a significantly lower incidence of hypoxemia ( = 0.002) and PONV ( = 0.021). Additionally, group A demonstrated overall more stable blood pressure and heart rate, as well as higher SpO levels.

CONCLUSION

For daytime hysteroscopy, alfentanil at a dose of 10 μg/kg is safer than sufentanil at a dose of 0.15 μg/kg when combined with propofol TCI.

TRIAL REGISTRATION

This study was registered with the Chinese Clinical Trial Registry (The URL of registration is https://www.chictr.org.cn/showproj.html?proj=177784; registration number: ChiCTR2200063939). The date of first registration was September 21, 2022.

摘要

背景

单次注射阿芬太尼或舒芬太尼,联合丙泊酚靶控输注(TCI),是日间宫腔镜检查常用的麻醉方案。

目的

本研究旨在评估和比较阿芬太尼和舒芬太尼在日间宫腔镜检查中的安全性和有效性。

设计

总共160例计划进行日间宫腔镜检查的患者被随机分为两组:A组和S组分别单次静脉注射阿芬太尼10μg/kg或舒芬太尼0.15μg/kg。两组均给予丙泊酚TCI进行镇静。

方法

从麻醉前至术后2小时监测生命体征。主要观察指标为低氧血症,定义为SpO水平低于92%持续30秒,这需要手动进行正压通气。次要观察指标包括各种围手术期并发症,如术后2小时出现的术后恶心呕吐(PONV),以及血流动力学指标、疼痛的数字评分量表(NRS)评分和其他麻醉相关数据。这个综合数据集被精心记录,随后进行分析以作比较。

结果

分析显示,A组的低氧血症发生率(P = 0.002)和PONV发生率(P = 0.021)显著更低。此外,A组的血压和心率总体上更稳定,SpO水平更高。

结论

对于日间宫腔镜检查,与丙泊酚TCI联合使用时,10μg/kg剂量的阿芬太尼比0.15μg/kg剂量的舒芬太尼更安全。

试验注册

本研究已在中国临床试验注册中心注册(注册网址为https://www.chictr.org.cn/showproj.html?proj=177784;注册号:ChiCTR2200063939)。首次注册日期为2022年9月21日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e65a/11528634/5a1738c9f562/10.1177_20420986241292231-fig1.jpg

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