Department of Anaesthesiology, Maternal and Child Health Hospital of Hubei Province, Wuhan, China.
School of Nursing, Hong Kong Polytechnic University, Hong Kong, SAR, China.
Clin Transl Sci. 2023 Sep;16(9):1606-1616. doi: 10.1111/cts.13572. Epub 2023 Jun 30.
Remimazolam is a new benzodiazepine with a short half-life, good efficacy, and safety profiles in general anesthesia. Combining esketamine with propofol (P + E) could reduce propofol consumption and injection pain. It is, however, unclear if a low dose of remimazolam co-administrated with esketamine (R + E) is comparable to the increasingly used P + E for surgical abortion with general anesthetic. We conducted a double-blind randomized controlled trial to compare the efficacy and safety of R + E and P + E. Two hundred patients scheduled for a surgical abortion were randomized to receive remimazolam 0.3 mg/kg plus esketamine 0.3 mg/kg (R + E), and propofol 2 mg/kg plus esketamine 0.3 mg/kg (P + E). Sedative effectiveness was evaluated by measuring the time to lose consciousness (LOC), recovery time, and successful sedation rate. Safety was assessed by hemodynamics and adverse events during and postoperation. The time to LOC and recovery time in R + E was 5 s shorter and 1 min longer than that in P + E, respectively (both p < 0.001). Success sedation rate did not differ between groups (p = 0.73). Bradycardia incidence and injection site pain were less frequent in the R + E group than that in the P + E group. More rash was observed in the R + E group compared with the P + E group (32% vs. 5%, p < 0.001), but all were mild (only chest rash) and resolved subsequently. Low dose of remimazolam when combined with esketamine has favorable profiles with rapid onset and recovery, but mild hemodynamic side effects and adverse events. It can be used as an alternative for surgical abortion with general anesthetic.
瑞马唑仑是一种新型苯二氮䓬类药物,具有半衰期短、疗效好、安全性高的特点,在全身麻醉中得到广泛应用。将依托咪酯与丙泊酚(P+E)联合使用可以减少丙泊酚的用量和注射痛。然而,尚不清楚小剂量瑞马唑仑联合依托咪酯(R+E)与广泛使用的 P+E 相比,在全身麻醉下进行人工流产手术是否具有可比性。我们进行了一项双盲随机对照试验,以比较 R+E 和 P+E 的疗效和安全性。将 200 名计划行人工流产术的患者随机分为瑞马唑仑 0.3mg/kg 联合依托咪酯 0.3mg/kg(R+E)组和丙泊酚 2mg/kg 联合依托咪酯 0.3mg/kg(P+E)组。通过记录意识消失时间(LOC)、苏醒时间和镇静成功率来评估镇静效果。通过术中及术后的血流动力学和不良反应来评估安全性。R+E 组的 LOC 时间和苏醒时间分别比 P+E 组短 5s 和长 1min(均 p<0.001)。两组的镇静成功率无差异(p=0.73)。R+E 组的心动过缓发生率和注射部位疼痛发生率低于 P+E 组。R+E 组皮疹的发生率高于 P+E 组(32%比 5%,p<0.001),但均为轻度(仅胸部皮疹),随后自行消退。小剂量瑞马唑仑联合依托咪酯具有起效快、恢复快的特点,但有轻微的血液动力学副作用和不良反应。可作为全身麻醉下人工流产术的替代药物。