瑞马唑仑用于预防全身麻醉下鼻腔手术后成人的苏醒期躁动：一项前瞻性随机临床对照试验。
Remimazolam for the prevention of emergence agitation in adults following nasal surgery under general anesthesia: a prospective randomized clinical controlled trial.
作者信息
Lu Yanfei, Xu Qiaomin, Dai Hong, Wu Jimin, Ai Mengting, Lan Haiyan, Dong Xiaoli, Duan Gongchen
机构信息
Center for Rehabilitation Medicine, Department of Anesthesiology, Affiliated People's Hospital, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, People's Republic of China.
Department of Anesthesiology, Lishui People's Hospital, The First Affiliated Hospital of Lishui University, Wenzhou Medical University Lishui Hospital, No. 1188, Liyang Street, Lishui, 323000, Zhejiang, People's Republic of China.
出版信息
BMC Anesthesiol. 2025 Jan 7;25(1):8. doi: 10.1186/s12871-024-02875-1.
BACKGROUND
Remimazolam is a novel intravenous sedative/anesthetic drug that belongs to the ultra-short-acting class of benzodiazepines. The purpose of this study was to evaluate the effectiveness of postoperative use of remimazolam in preventing emergence agitation (EA) in adults following nasal surgery.
METHODS
Patients who underwent nasal surgery were randomly divided into Group R and Group C. Propofol, sufentanil, and cis-atracurium were used for the induction of anesthesia, and 1.5-3.5% sevoflurane was used for the maintenance of anesthesia. At the end of the surgery, patients were randomly assigned to receive either remimazolam 0.1 mg kg (Group R, n = 43) or 0.9% saline (Group C, n = 43). The primary outcome was the incidence of EA, which was defined as a Riker Sedation-Agitation Scale score > 4. The secondary outcomes included the incidence of severe EA, anesthesia, surgery characteristics, adverse events, mean arterial pressure, and heart rate (at different time points).
RESULTS
A total of 86 adult patients completed the study. The incidence of EA was lower in Group R than in Group C (21% vs. 49%, P = 0.007). The incidence of severe EA was also lower in Group R than in Group C (2% vs. 19%, P = 0.035). The maximal Sedation-Agitation Scale score during emergence was lower in Group R 4 [range 4 to 4] than in Group C 5 [range 4 to 6] (P < 0.001). In addition, the incidence of hypertension and grade of cough in Group R were lower than in Group C (P = 0.024). During emergence, the mean arterial pressure and heart rate of group R showed more stability than those in group C.
CONCLUSIONS
Postoperative intravenous infusion of 0.1 mg/kg remimazolam into adult patients undergoing nasal surgery can reduce the incidence of EA and severe EA, and provide stable hemodynamics.
TRIAL REGISTRATION
The trial was registered, before patient enrollment, in the Chinese Clinical Trial Registry ( www.chictr.org.cn ) (clinical trial number: ChiCTR2300075300; Principal Investigator: Gongchen Duan; date of registration: 31 August 2023; https://www.chictr.org.cn/bin/project/edit?pid=203928 ).
背景
瑞马唑仑是一种新型静脉镇静/麻醉药物，属于超短效苯二氮䓬类。本研究的目的是评估瑞马唑仑术后用于预防鼻科手术后成人出现苏醒期躁动（EA）的有效性。
方法
接受鼻科手术的患者被随机分为R组和C组。麻醉诱导使用丙泊酚、舒芬太尼和顺式阿曲库铵，麻醉维持使用1.5 - 3.5%七氟醚。手术结束时，患者被随机分配接受0.1 mg/kg瑞马唑仑（R组，n = 43）或0.9%生理盐水（C组，n = 43）。主要结局是EA的发生率，定义为里克尔镇静 - 躁动量表评分>4。次要结局包括严重EA的发生率、麻醉、手术特征、不良事件、平均动脉压和心率（在不同时间点）。
结果
共有86例成年患者完成研究。R组的EA发生率低于C组（21%对49%，P = 0.007）。R组的严重EA发生率也低于C组（2%对19%，P = 0.035）。R组苏醒期最大镇静 - 躁动量表评分为4[范围4至4]，低于C组的5[范围4至6]（P < 0.001）。此外，R组高血压发生率和咳嗽分级低于C组（P = 0.024）。苏醒期，R组的平均动脉压和心率比C组更稳定。
结论
对接受鼻科手术的成年患者术后静脉输注0.1 mg/kg瑞马唑仑可降低EA和严重EA的发生率，并提供稳定的血流动力学。
试验注册
该试验在患者入组前在中国临床试验注册中心（www.chictr.org.cn）注册（临床试验编号：ChiCTR2300075300；主要研究者：段功晨；注册日期：2023年8月31日；https://www.chictr.org.cn/bin/project/edit?pid=203928）。
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