甲苯磺酸瑞马唑仑与丙泊酚用于日间手术患者的有效性和安全性：一项前瞻性随机对照试验。
Efficacy and safety of remimazolam tosilate versus propofol in patients undergoing day surgery: a prospective randomized controlled trial.
机构信息
Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, 200032, People's Republic of China.
School of Anesthesiology, Xuzhou Medical University, Xuzhou, People's Republic of China.
出版信息
BMC Anesthesiol. 2023 May 26;23(1):182. doi: 10.1186/s12871-023-02092-2.
BACKGROUND
Remimazolam tosilate (RT) is a novel short-acting GABA (A) receptor agonist that has a rapid recovery from procedural sedation and can be fully reversed by flumazenil. To date, there have been relatively few articles comparing RT and propofol for general anesthesia. This study aimed to assess the efficacy and safety of RT with or without flumazenil compared with propofol in general anesthesia for day surgery.
METHODS
115 patients scheduled for day surgery were randomized into three groups: RT (n = 39), RT + flumazenil (n = 38) and propofol (n = 38). The primary endpoints were anesthesia induction time and time until fully alert. Anesthesia success rate, bispectral index (BIS) values, injection pain, opioid and vasopressor dosages, postoperative recovery profiles and perioperative inflammatory and cognitive changes were assessed. Any adverse events were recorded.
RESULTS
Induction times were similar among the three groups (P = 0.437), but the median time until fully alert in patients treated with RT was longer than that of the propofol or RT + flumazenil groups (17.6 min vs. 12.3 min vs. 12.3 min, P < 0.001). The three groups had comparable postoperative recovery quality and inflammatory and cognitive state changes (P > 0.05). Smaller percentages of patients who received RT (26.3%) and RT + flumazenil (31.6%) developed hypotension during anesthesia maintenance compared with propofol (68.4%), and consequently less ephedrine (P < 0.001) and phenylephrine (P = 0.015) were needed in the RT group. Furthermore, serum triglyceride levels were lower (P < 0.001) and injection pain was much less frequent in the RT with or without flumazenil groups compared with the propofol group (5.3% vs. 0% vs. 18.4%).
CONCLUSION
RT permits rapid induction and comparable recovery profile compared with propofol in general anesthesia for day surgery, but has a prolonged recovery time without flumazenil. The safety profile of RT was superior to propofol in terms of hypotension and injection pain.
TRIAL REGISTRATION
The study was registered at Chinese Clinical Trial Registry http://www.chictr.org.cn/ (Registration date: 19/7/2021; Trial ID: ChiCTR2100048904).
背景
甲苯磺酸瑞马唑仑（RT）是一种新型的 GABA（A）受体激动剂，具有从程序镇静中快速恢复的特点，并可被氟马西尼完全逆转。迄今为止，比较 RT 和丙泊酚用于全身麻醉的文章相对较少。本研究旨在评估 RT 联合或不联合氟马西尼与丙泊酚用于日间手术全身麻醉的疗效和安全性。
方法
115 例行日间手术的患者随机分为三组：RT 组（n=39）、RT+氟马西尼组（n=38）和丙泊酚组（n=38）。主要终点为麻醉诱导时间和完全清醒时间。评估麻醉成功率、脑电双频指数（BIS）值、注射痛、阿片类药物和血管加压药剂量、术后恢复情况以及围手术期炎症和认知变化。记录任何不良事件。
结果
三组患者的诱导时间相似（P=0.437），但 RT 组患者完全清醒的中位时间长于丙泊酚组或 RT+氟马西尼组（17.6 min 比 12.3 min 比 12.3 min，P<0.001）。三组患者的术后恢复质量、炎症和认知状态变化无差异（P>0.05）。与丙泊酚组（68.4%）相比，接受 RT（26.3%）和 RT+氟马西尼（31.6%）的患者在麻醉维持期间发生低血压的比例较小，因此需要更少的麻黄碱（P<0.001）和去氧肾上腺素（P=0.015）。此外，与丙泊酚组相比，RT 组和 RT+氟马西尼组的血清甘油三酯水平更低（P<0.001），注射痛的发生率更低（5.3%比 0%比 18.4%）。
结论
RT 与丙泊酚相比，在日间手术全身麻醉中具有快速诱导和相似的恢复特征，但无氟马西尼时恢复时间延长。在低血压和注射痛方面，RT 的安全性优于丙泊酚。
试验注册
本研究在中国临床试验注册中心注册，网址为 http://www.chictr.org.cn/（注册日期：2021 年 7 月 19 日；注册号：ChiCTR2100048904）。
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