Lu Xiaoxing, Zhou Meiyan, Lu Yao, Sun Jia, Mao Kexin, Zhu Yangzi, Wang Rongguo, Cao Yong, Wang Liwei
Suzhou Medical College of Soochow University, Soochow, Jiangsu, China.
Department of Anesthesiology, Southeast University Affiliated Xuzhou Central Hospital, Xuzhou, Jiangsu, China.
Front Med (Lausanne). 2025 Aug 19;12:1612779. doi: 10.3389/fmed.2025.1612779. eCollection 2025.
Emergence agitation (EA) is a common postoperative complication characterized by confusion, disorientation, and restless behavior that can lead to self-harm, the removal of medical devices, and other adverse events. This randomized, double-blind, placebo-controlled study was designed to assess the efficacy and safety of a novel benzodiazepine, remimazolam, in the management of EA.
A total of 219 adults experienced EA (Riker Sedation-Agitation Scale SAS score ≥5) after otolaryngological surgery were randomly assigned (1:1:1 ratio) to receive one of the following three treatments: 2.5 mg remimazolam, 5.0 mg remimazolam, or placebo. The primary endpoint was the treatment success rate of EA, which was defined as an SAS score of <5 within 15 min after administration without the need for rescue sedation and no recurrence after 15 min. Secondary outcomes included rescue propofol dosage, EA duration, and the post-anesthesia care unit (PACU) discharge time. Adverse events were also monitored.
Both remimazolam groups (77.5% for 2.5 mg and 85.9% for 5.0 mg) had significantly higher treatment success rates compared to the placebo group (44.3%) (both < 0.001). Additionally, they required less rescue propofol, had shorter EA durations, and faster PACU discharge times (all < 0.001). Furthermore, the 2.5 mg group showed a lower incidence of hypoxia (7.0%) and hypotension (14.1%) compared to the placebo group (22.9% for hypoxia, 31.4% for hypotension) ( = 0.024 and 0.042, respectively). Exploratory analysis indicated that, for patients with dangerous agitation (SAS = 7), only the 5.0 mg group (83.3%) had a significantly higher treatment success rate than the placebo group (0%) ( < 0.001).
Our findings suggest that remimazolam is a promising option for managing EA in the PACU. For the entire study population, the 2.5 mg dose strikes an optimal balance between efficacy and safety. In patients with dangerous agitation, a 5.0 mg dose of remimazolam may offer potential benefits. These findings hold significant implications for guiding future therapeutic strategies for EA.
https://www.chictr.org.cn/, identifier ChiCTR2400085903.
苏醒期躁动（EA）是一种常见的术后并发症，其特征为意识模糊、定向障碍和躁动行为，可导致自残、拔除医疗设备及其他不良事件。本随机、双盲、安慰剂对照研究旨在评估新型苯二氮䓬类药物瑞马唑仑用于管理EA的疗效和安全性。
共有219例耳鼻喉科手术后发生EA（Riker镇静-躁动评分量表[SAS]评分≥5）的成年人被随机分配（1:1:1比例）接受以下三种治疗之一：2.5mg瑞马唑仑、5.0mg瑞马唑仑或安慰剂。主要终点为EA的治疗成功率，定义为给药后15分钟内SAS评分<5，无需抢救性镇静且15分钟后无复发。次要结局包括抢救用丙泊酚剂量、EA持续时间及麻醉后监护病房（PACU）出院时间。同时监测不良事件。
与安慰剂组（44.3%）相比，两个瑞马唑仑组（2.5mg组为77.5%，5.0mg组为85.9%）的治疗成功率均显著更高（均P<0.001）。此外，它们所需的抢救用丙泊酚更少，EA持续时间更短，PACU出院时间更快（均P<0.001）。此外，2.5mg组的低氧血症（7.0%）和低血压发生率（14.1%）低于安慰剂组（低氧血症为22.9%，低血压为31.4%）（分别为P=0.024和0.042）。探索性分析表明，对于有危险躁动（SAS=7）的患者，只有5.0mg组（83.3%）的治疗成功率显著高于安慰剂组（0%）（P<0.001）。
我们的研究结果表明，瑞马唑仑是在PACU管理EA的一个有前景的选择。对于整个研究人群，2.5mg剂量在疗效和安全性之间达到了最佳平衡。对于有危险躁动的患者，5.0mg剂量的瑞马唑仑可能有潜在益处。这些发现对指导未来EA的治疗策略具有重要意义。
