Adverse events and postoperative follow up.

ObjectiveThe optimal sedation strategy for gastrointestinal endoscopy remains debated. This study compared the efficacy and safety of remimazolam combined with etomidate versus propofol for procedural sedation during gastrointestinal endoscopy.MethodsThis single-center, randomized controlled clinical trial was performed from March 2024 to April 2024. A total of 262 patients scheduled to undergo gastrointestinal endoscopy were randomly assigned to receive remimazolam-etomidate (RE) or remimazolam-propofol (RP). The primary outcome was the incidence of respiratory depression. Secondary outcomes included the results of sedation and recovery. The safety results mainly include the incidence of hypotension, bradycardia, tachycardia, painful injection and muscular tremor. Statistical analyses included t-tests, Mann-Whitney U tests, and χ² tests for group comparisons, with subgroup analyses and multivariable logistic regression to assess the robustness of primary outcome.ResultsRespiratory depression occurred in 20.0% (25/125) of RE patients versus 32.3% (40/124) of RP patients (OR=0.52; 95% CI = 0.29–0.93; p = 0.028). There was a statistically significant difference in the distribution of the number of airway interventions between the two groups (p = 0.043), with 18 patients (14.5%) in the RP group requiring three airway interventions and only seven patients (5.6%) in the RE group. Hypoxemia occurred in three patients (2.4%) in the RE group and in five patients (4.0%) in the RP group. Hypotension was observed in 23.2% of patients sedated with RE versus 36.3% of patients sedated with RP (p = 0.024).ConclusionRemimazolam-etomidate demonstrated a superior safety profile, with reduced respiratory depression and hemodynamic instability compared to remimazolam-propofol, suggesting its potential as a safer alternative for gastrointestinal endoscopy sedation.Registration informationThis trial was prospectively registered at the Chinese Clinical Trial Registry (ChiCTR2400085904) prior to patient enrollment.

研究目的：胃肠道内镜检查的最优镇静策略仍存在争议。本研究对比了瑞马唑仑（remimazolam）联合依托咪酯（etomidate）与丙泊酚（propofol）用于胃肠道内镜检查术中操作镇静的有效性与安全性。
方法：本项单中心随机对照临床试验于2024年3月至2024年4月开展。共计纳入262例拟行胃肠道内镜检查的患者，按随机分组原则分别接受瑞马唑仑-依托咪酯（RE）或瑞马唑仑-丙泊酚（RP）镇静方案。主要结局指标为呼吸抑制发生率；次要结局指标包括镇静效果及恢复相关指标。安全性指标主要包括低血压、心动过缓、心动过速、注射痛及肌肉震颤的发生率。统计学分析采用t检验、Mann-Whitney U检验及χ²检验进行组间比较，并通过亚组分析与多变量logistic回归评估主要结局指标的稳健性。
结果：瑞马唑仑-依托咪酯组患者呼吸抑制发生率为20.0%（25/125），瑞马唑仑-丙泊酚组为32.3%（40/124）（比值比（odds ratio, OR）=0.52；95%置信区间（confidence interval, CI）=0.29–0.93；P=0.028）。两组气道干预措施次数的分布差异具有统计学意义（P=0.043），其中瑞马唑仑-丙泊酚组有18例患者（14.5%）需行3次气道干预，而瑞马唑仑-依托咪酯组仅7例（5.6%）。瑞马唑仑-依托咪酯组低氧血症发生率为2.4%（3/125），瑞马唑仑-丙泊酚组为4.0%（5/124）。瑞马唑仑-依托咪酯组低血压发生率为23.2%，低于瑞马唑仑-丙泊酚组的36.3%（P=0.024）。
结论：相较于瑞马唑仑-丙泊酚方案，瑞马唑仑-依托咪酯镇静方案展现出更优的安全性，可降低呼吸抑制与血流动力学不稳定的发生风险，提示其有望成为胃肠道内镜检查镇静的更安全替代方案。
注册信息：本试验已于患者入组前在中国临床试验注册中心（Chinese Clinical Trial Registry）完成前瞻性注册，注册号为ChiCTR2400085904。