Department of Anesthesiology and Critical Care Medicine, Tianjin Nankai Hospital, Tianjin Medical University, No. 6, Changjiang Road, Tianjin, China.
Department of Epidemiology, Tianjin Neurological Institute and Department of Neurology, Tianjin Medical University General Hospital, No. 154, Anshan Road, Tianjin, China.
J Clin Anesth. 2023 Jun;86:111077. doi: 10.1016/j.jclinane.2023.111077. Epub 2023 Feb 9.
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.
A randomized, controlled, single-center trial.
The Endoscopic Centre of Tianjin Nankai Hospital, China.
518 patients undergoing elective ERCP under deep sedation.
Patients scheduled for ERCP were randomly assigned to be sedated with either a combination of remimazolam-alfentanil or propofol-alfentanil.
The primary outcome was the prevalence of hypoxia, which was defined as SpO < 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).
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.
During elective ERCP, patients administered with remimazolam showed fewer respiratory depression events under deep sedation with hemodynamic advantages over propofol when administered in combination with alfentanil.
在许多国家，将丙泊酚和阿片类药物联合使用作为 ERCP 期间首选的镇静方案。然而，丙泊酚镇静最严重的风险是缺氧和低血压。与咪达唑仑相比，瑞马唑仑具有更快的催眠作用起效和消退时间，以及更稳定的心肺功能，要实现程序镇静的广泛接受，瑞马唑仑必须取代最常用于程序镇静的丙泊酚。本研究的目的是比较瑞马唑仑和丙泊酚联合阿芬太尼在 ERCP 手术中镇静时的安全性和疗效。
随机、对照、单中心试验。
中国天津市南开医院内镜中心。
518 例接受择期 ERCP 深度镇静的患者。
接受 ERCP 的患者被随机分配接受瑞马唑仑-阿芬太尼或丙泊酚-阿芬太尼联合镇静。
主要结局是缺氧的发生率，定义为 SpO2<90%超过 10s。其他结局包括气道操作、手术和镇静相关结局和副作用（如恶心、呕吐和心血管不良事件）的需要。
共 518 例患者进行了随机分组。其中，250 例患者被分配到瑞马唑仑组，255 例患者被分配到丙泊酚组。在 ERCP 过程中，瑞马唑仑组有 9.6%的患者出现缺氧，而丙泊酚组有 15.7%的患者出现缺氧（p=0.04）。由于缺氧需要气道操作的患者在丙泊酚组中明显更多（p=0.04）。此外，接受瑞马唑仑镇静的患者低血压的发生率低于接受丙泊酚镇静的患者（p<0.001）。接受瑞马唑仑镇静的患者满意度评分更高，并推荐在下一次 ERCP 中使用相同的镇静。由于患者疾病的复杂性，瑞马唑仑组的手术时间明显长于丙泊酚组，导致镇静时间延长。
在择期 ERCP 中，与丙泊酚相比，在联合使用阿芬太尼时，瑞马唑仑镇静下接受深度镇静的患者呼吸抑制事件更少，具有血流动力学优势。
