He Yanhua, Zhou Jie, Ding Xibing, Huai Xiaorong, Lin Shujing, Yu Weifeng, Su Diansan
Department of Anesthesiology, School of Medicine, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.
Department of Anesthesiology, The First Affiliated Hospital, Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 310003, China.
Trials. 2025 Aug 26;26(1):309. doi: 10.1186/s13063-025-09054-8.
Hypoxemia is the most common adverse reaction during sedated hysteroscopy. Obesity is a risk factor for hypoxemia. For hysteroscopy, propofol is the most commonly used sedative. However, it can cause dose-dependent respiratory depression. This drawback has driven the search for sedatives with less respiratory depressant effects. Remimazolam is a new benzodiazepine drug with several advantages, including minimal impact on the respiratory and circulatory systems. This study aims to compare remimazolam and propofol in terms of safety and efficacy in patients with overweight or obesity who are undergoing sedated hysteroscopy.
This prospective, single-center, randomized, single-blind, controlled clinical trial will be conducted to examine the effect of remimazolam on the incidence of severe hypoxemia in patients with overweight or obesity. Patients (n = 600) scheduled to undergo sedated hysteroscopy will be randomly assigned to either the control or experimental group and will be sedated using propofol or remimazolam, respectively.
The main objective of this study is to determine whether remimazolam can reduce the incidence of severe hypoxemia in patients with overweight or obesity during hysteroscopy. The results of this study are expected to provide evidence on the safety and efficacy of remimazolam in patients with overweight or obesity, which will enhance patient comfort and safety during sedated hysteroscopy.
ClinicalTrials.gov NCT06187896. Registered on January 3, 2024.
低氧血症是镇静宫腔镜检查期间最常见的不良反应。肥胖是低氧血症的一个危险因素。对于宫腔镜检查，丙泊酚是最常用的镇静剂。然而，它可引起剂量依赖性呼吸抑制。这一缺点促使人们寻找呼吸抑制作用较小的镇静剂。瑞马唑仑是一种新型苯二氮䓬类药物，具有多种优势，包括对呼吸和循环系统影响极小。本研究旨在比较瑞马唑仑和丙泊酚在接受镇静宫腔镜检查的超重或肥胖患者中的安全性和有效性。
将进行这项前瞻性、单中心、随机、单盲、对照临床试验，以研究瑞马唑仑对超重或肥胖患者严重低氧血症发生率的影响。计划接受镇静宫腔镜检查的患者（n = 600）将被随机分配到对照组或试验组，分别使用丙泊酚或瑞马唑仑进行镇静。
本研究的主要目的是确定瑞马唑仑是否能降低超重或肥胖患者宫腔镜检查期间严重低氧血症的发生率。本研究结果有望为瑞马唑仑在超重或肥胖患者中的安全性和有效性提供证据，这将提高镇静宫腔镜检查期间患者的舒适度和安全性。
ClinicalTrials.gov NCT06187896。于2024年1月3日注册。
