[Comparison of the effects of general anesthesia between remimazolam and propofol in pediatric patients undergoing binocular strabismus day surgery]

Zhonghua Yi Xue Za Zhi. 2024 Jul 30;104(29):2728-2733. doi: 10.3760/cma.j.cn112137-20231209-01331.
[Article in Chinese]

Abstract

Objective: To compare the effects of general anesthesia between remimazolam and propofol in pediatric patients undergoing binocular strabismus day surgery. Methods: Prospectively, 60 pediatric patients, American Society of Anesthesiologists (ASA) grade Ⅰ-Ⅱ, scheduled to undergo binocular strabismus daytime surgery in Beijing Tongren Hospital under general anesthesia with laryngeal mask airway from December 2021 to May 2022 were selected. They were randomly divided into Remimazolam group and Propofol group with 30 cases in each group, according to the ratio of 1∶1 by SPSS program. Patients in Remimazolam group were induced by remimazolam, remifentanil and micuronium chloride, and maintained by remimazolam and remifentanil. Patients in Propofol group were induced by propofol, remifentanil and micuronium chloride, and maintained by propofol and remifentanil. Patients in Remimazolam group were given 0.1 mg of flumazenil for antagonism 3 minutes after operation, while children in Propofol group waited for natural awakening. The primary outcome was the time from drug withdrawal to laryngeal mask removal after operation. The secondary outcomes included the time for consciousness loss during induction, intraoperative hemodynamic data [mean arterial pressure (MAP) and heart rate], the success rate of sedation, the awareness rate during operation, and the incidence of adverse events after admission to postanesthesia care unit(PACU). Results: The Remimazolam group included 12 males and 18 females, aged (5.0±1.4) years. There were 14 males and 16 females in the Propofol group, aged (5.3±1.3) years. The time from drug withdrawal to laryngeal mask removal in Remimazolam group was (6.5±1.2) min, which was shorter than that in Propofol group of (10.7±1.9) min (P<0.001). The time for consciousness loss during induction was (38.1±4.8) s in Remimazolam group, which was longer than that in Propofol group of (31.6±4.9) s (P<0.001). The variability of MAP and heart rate of patients during operation in Remimazolam group was lower than that in Propofol group (all P<0.05). There was no significant difference in sedation success rate, intraoperative awareness and adverse reactions in PACU between the two groups (all P>0.05). Conclusion: In pediatric patients with binocular strabismus during daytime surgery, general anesthesia with remimazolam can shorten the time from drug withdrawal to laryngeal mask removal after operation without increasing the incidence of postoperative adverse reactions and can provide more stable hemodynamics.

目的: 比较瑞马唑仑与丙泊酚用于双眼斜视矫正日间手术患儿全身麻醉的效果。 方法: 前瞻性纳入2021年12月至2022年5月于北京同仁医院接受择期喉罩全身麻醉双眼斜视矫正日间手术的患儿60例,美国麻醉医师协会(ASA)分级Ⅰ~Ⅱ级。采用SPSS随机化程序按照1∶1比例将患儿随机分配到瑞马唑仑组和丙泊酚组,每组30例。瑞马唑仑组给予瑞马唑仑、瑞芬太尼及米库氯铵诱导,瑞马唑仑和瑞芬太尼麻醉维持。丙泊酚组给予丙泊酚、瑞芬太尼及米库氯铵诱导,丙泊酚和瑞芬太尼麻醉维持。瑞马唑仑组术毕3 min给予患儿氟马西尼0.1 mg拮抗,丙泊酚组等待患儿自然苏醒。主要观察指标为术毕停药到拔除喉罩所需时间;次要观察指标包括诱导期给药到患者意识消失所需时间、术中血流动力学指标[平均动脉压(MAP)和心率]、镇静成功率、术中知晓率、麻醉后恢复室(PACU)不良反应发生率等。 结果: 瑞马唑仑组男12例,女18例,年龄(5.0±1.4)岁。丙泊酚组男14例,女16例,年龄(5.3±1.3)岁。瑞马唑仑组患儿术毕停药到拔除喉罩所需时间为(6.5±1.2)min,短于丙泊酚组的(10.7±1.9)min(P<0.001)。瑞马唑仑组患儿诱导期给药到意识消失所需时间为(38.1±4.8)s,长于丙泊酚组的(31.6±4.9)s(P<0.001)。瑞马唑仑组术中MAP和心率的变异性均低于丙泊酚组(均P<0.05)。两组患儿镇静成功率、术中知晓率及PACU不良反应发生率差异均无统计学意义(均P>0.05)。 结论: 对于接受双眼斜视矫正日间手术患儿,采用瑞马唑仑进行全身麻醉在不增加术后不良反应发生率的情况下,可缩短术毕停药至拔除喉罩所需时间,且术中血流动力学更稳定。.

Publication types

  • Randomized Controlled Trial
  • Comparative Study
  • English Abstract

MeSH terms

  • Anesthesia Recovery Period
  • Anesthesia, General*
  • Anesthetics, Intravenous / administration & dosage
  • Benzodiazepines / therapeutic use
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Male
  • Propofol* / administration & dosage
  • Prospective Studies
  • Strabismus* / surgery

Substances

  • Propofol
  • remimazolam
  • Benzodiazepines
  • Anesthetics, Intravenous