瑞马唑仑与丙泊酚联合阿芬太尼用于内镜逆行胰胆管造影中的镇静比较：一项随机对照临床试验

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瑞马唑仑与丙泊酚联合阿芬太尼用于内镜逆行胰胆管造影（ERCP）中的镇静比较：一项随机对照临床试验

贵州医科大学    麻醉与心脏电生理课题组

翻译：潘志军

编辑：宋雨婷

审校：曹莹

1背景

在许多国家，内镜逆行胰胆管造影（ERCP）期间的首选镇静方案为丙泊酚和阿片类药物的复合麻醉。然而，丙泊酚用于镇静最严重的副作用是缺氧和低血压。与咪达唑仑相比，瑞马唑仑用于镇静具有起效快、失效快，以及心肺稳定性的特点。在程序化镇静方面，瑞马唑仑若想要被广泛使用，则其药理作用需优于最常用的程序化镇静药物——丙泊酚。本研究的目的是比较瑞马唑仑和丙泊酚联合阿芬太尼用于ERCP手术镇静时的安全性和有效性。

2设计、地点、受试对 象及干预措施

该试验为一项随机、对照、单中心试验，于天津市南开医院内镜中心开展。将518例在深度镇静下接受择期ERCP的患者随机分为瑞马唑仑-阿芬太尼组和丙泊酚-阿芬太尼组。

3方法

主要结局指标是缺氧的发生率（将缺氧定义为SpO2 < 90%且持续时间大于10s）。次要结局指标包括需要干预以维持受试者呼吸道通畅的情况、手术过程、镇静相关指标和副作用（如恶心、呕吐和心血管不良事件）。

4结果

将518例患者进行随机分组，其中瑞马唑仑组250例，丙泊酚组255例。在ERCP过程中，9.6 %的瑞马唑仑组患者出现缺氧，而15.7 %的丙泊酚组患者出现缺氧( P = 0.04 )。丙泊酚组患者因缺氧需要干预以维持受试者呼吸道通畅的比率显著增高(P = 0.04 )。此外，使用瑞马唑仑镇静的患者发生低血压的比率低于使用丙泊酚镇静的患者( P < 0.001 )。接受瑞马唑仑镇静的患者表现出更高的满意度评分，并推荐用于下一次ERCP。瑞马唑仑组由于患者病情复杂，手术时间远长于丙泊酚组，导致镇静时间较久。

5结论

在ERCP期间，与丙泊酚联合阿芬太尼相比，给予瑞马唑仑的患者在深度镇静下表现出较少的呼吸抑制和较高的血流动力学优势。

原始文献来源：

Shu-An Dong,Yan Guo, Sha-Sha Liu,et al. A randomized, controlled clinical trial comparing remimazolam to propofol when combined with alfentanil for sedation during ERCP procedures [J]. (J Clin Anesth. 2023 Jun;86:111077).

英文原文

A randomized, controlled clinical trial comparing remimazolam to propofol when combined with alfentanil for sedation during ERCP procedures       

Study objective: In many countries, the combination of propofol and opioid is used as the preferred sedative regime during ERCP. However, the most serious risks of propofol sedation are oxygen deficiency and hypotension. Compared to midazolam, remimazolam has a faster onset and offset of hypnotic effect, as well as cardiorespiratory stability, and to achieve widespread acceptance for procedural sedation, remimazolam must replace propofol which is the most commonly used for procedural sedation. The objective of this study was to compare the safety and efficacy profiles of the remimazolam and propofol when combined with alfentanil for sedation during ERCP procedures.

Design: A randomized, controlled, single-center trial.

Setting: The Endoscopic Centre of Tianjin Nankai Hospital, China.

Patients: 518 patients undergoing elective ERCP under deep sedation.

Interventions: Patients scheduled for ERCP were randomly assigned to be sedated with either a combination of remimazolam-alfentanil or propofol-alfentanil.

Measurements: The primary outcome was the prevalence of hypoxia, which was defined as SpO2 < 90% for >10 s. Other outcomes were the need for airway maneuver, procedure, and sedation-related outcomes and side effects (e.g., nausea, vomiting, and cardiovascular adverse events).

Main results: A total of 518 patients underwent randomization. Of these, 250 were assigned to the remimazolam group and 255 to the propofol group. During ERCP, 9.6% of patients in the remimazolam group showed hypoxia, while in the propofol group, 15.7% showed hypoxia (p=0.04). The need for airway maneuvering due to hypoxia was significantly greater in the propofol group (p=0.04). Furthermore, patients sedated with remimazolam had a lower percentage of hypotension than patients sedated with propofol (p<0.001). Patients receiving remimazolam sedation expressed higher satisfaction scores and were recommended the same sedation for the next ERCP. The procedure time in the remimazolam group was much longer than in the propofol group due to the complexity of the patient's disease, which resulted in a longer sedation time.

Conclusion: During elective ERCP, patients administered with remimazolam showed fewer respiratory depression events under deep sedation with hemodynamic advantages over propofol when administered in combination.

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编辑：Michel.米萱

校对：MiLu.米鹭

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