甲苯磺酸瑞马唑仑和丙泊酚用于腹腔镜疝囊高位结扎术患儿全身麻醉效果的比较
收稿日期: 2025-09-30
修回日期: 2025-10-22
录用日期: 2025-12-24
网络出版日期: 2026-01-26
基金资助
科技创新2030-“脑科学与类脑研究”重大项目(2021ZD0203100)
Comparison of Remimazolam Tosilate and Propofol for General Anesthesia in Pediatric Patients Undergoing Laparoscopic High Ligation of the Hernial Sac
Received date: 2025-09-30
Revised date: 2025-10-22
Accepted date: 2025-12-24
Online published: 2026-01-26
Supported by
目的:比较静脉麻醉药甲苯磺酸瑞马唑仑和丙泊酚在儿童腹腔镜疝囊高位结扎术中的临床应用效果及围术期安全性。方法:纳入2024年3~11月在我院接受择期腹腔镜疝囊高位结扎术的60例2~6岁、ASA分级Ⅰ~Ⅱ级患儿,随机分为瑞马唑仑组(R组,n=30)和丙泊酚组(P组,n=30)。R组采用甲苯磺酸瑞马唑仑(以下简称瑞马唑仑)复合舒芬太尼、顺阿曲库铵进行麻醉诱导,维持阶段持续输注瑞马唑仑与瑞芬太尼;P组使用丙泊酚联合相同辅助药物实施麻醉。术毕所有患儿均转入麻醉后恢复室(PACU)观察。主要终点为镇静成功率,次要终点包括诱导期的血流动力学变化(平均动脉压、心率、指脉博氧饱和度)、围术期时间指标(手术时间、麻醉时间、喉罩拔除时间、意识恢复时间、PACU停留时间)以及围术期不良事件发生情况。结果:R组镇静成功率与P组比较,差异无统计学意义(P>0.05)。R组诱导期T1和T2时间点的MAP均高于P组(P<0.05)。两组在围术期时间指标及术后不良事件发生率方面比较,差异均无统计学意义(P>0.05)。结论:瑞马唑仑用于2~6岁小儿腹腔镜疝囊高位结扎术全身麻醉时,其麻醉效能与丙泊酚相当,且能提供更平稳的诱导期血流动力学状态,可作为该年龄段腹腔镜手术全身麻醉的一种安全、可行的替代方案。
范高飞
,
康芳
.
甲苯磺酸瑞马唑仑和丙泊酚用于腹腔镜疝囊高位结扎术患儿全身麻醉效果的比较
Objective: To compare the efficacy and safety of remimazolam tosilate versus propofol in general anesthesia for pediatric patients undergoing laparoscopic high ligation of the hernial sac.Methods: Sixty children aged 2 to 6 years, classified as ASA Ⅰ or Ⅱ, who underwent laparoscopic high ligation of the hernial sac under laryngeal mask general anesthesia in our hospital from March 2024 to November 2024 were included and randomly divided into the remimazolam group (group R, n=30) and the propofol group (group P, n=30). In group R, anesthetic induction utilized remimazolam tosilate (hereinafter referred to as remimazolam), sufentanil, and cisatracurium, with maintenance via remimazolam and remifentanil infusion. Group P received propofol, sufentanil, and cisatracurium for induction, followed by propofol and remifentanil maintenance. After the openation, all patients were transferred to the post-anesthesia care unit (PACU) for recovery management. The primary outcome was the sedation success rate. Secondary outcomes included hemodynamic parameters (MAP, HR, SpO2) during induction, operative duration, anesthesia duration, time of laryngeal mask removal, time of consciousness recovery, PACU discharge time, and the incidence of adverse events.Results: The sedation success rate in group R was not statistically different from that in group P (P > 0.05). The MAP at T1 and T2 time points during induction in group R was higher than that of group P (P < 0.05). No statistically significant differences were observed in recovery time, laryngeal mask removal time, PACU stay duration, or the incidence of postoperative adverse events (P>0.05).Conclusions: Remimazolam demonstrates non-inferior efficacy to propofol for general anesthesia in children aged 2-6 years undergoing laparoscopic high ligation of the hernial sac, with superior hemodynamic stability during induction. These findings support remimazolam as a safe and viable alternative for general anesthesia for laparoscopic surgery in this pediatric population.
[1] Niu X, Song X, Su A, et al. Low-pressure capnoperitoneum reduces stress responses during pediatric laparoscopic high ligation of indirect inguinal hernia sac: a randomized controlled study[J].Medicine (Baltimore), 2017, 96(14): e6563.
[2] Zhang Q, Yu Y, Lu Y, et al. Systematic review and meta-analysis of propofol versus barbiturates for controlling refractory status epilepticus[J].BMC Neurol, 2019,19(1):55.
[3] Brijs J, Van Eldere A, Breynaert C, et al. Transient phlebitis after propofol infusion: a mimic of hypersensitivity[J].J Allergy Clin Immunol Pract, 2020,8(1):330-331.
[4] Canbay O, Celebi N, Arun O, et al. Efficacy of intravenous acetaminophen and lidocaine on propofol injection pain[J].Br J Anaesth, 2008,100(1):95-98.
[5] Kilpatrick GJ, Mcintyre MS, Cox RF, et al. CNS 7056: a novel ultra-short-acting Benzodiazepine[J].Anesthesiology, 2007,107(1):60-66.
[6] Mao Y, Guo J, Yuan J, et al. Quality of recovery after general anesthesia with remimazolam in patients' undergoing urologic surgery: a randomized controlled trial comparing remimazolam with propofol[J].Drug Des Devel Ther, 2022,16:1199-1209.
[7] Choi JY, Lee HS, Kim JY, et al. Comparison of remimazolam-based and propofol-based total intravenous anesthesia on postoperative quality of recovery: a randomized non-inferiority trial[J].J Clin Anesth, 2022,82:110955.
[8] Chae D, Kim HC, Song Y, et al. Pharmacodynamic analysis of intravenous bolus remimazolam for loss of consciousness in patients undergoing general anaesthesia: a randomised, prospective, double-blind study[J].Br J Anaesth, 2022,129(1):49-57.
[9] Kilpatrick GJ. Remimazolam: non-clinical and clinical profile of a new sedative/anesthetic agent[J].Front Pharmacol, 2021,12:690875.
[10] 拾翠翠,孙剑,张玉凤.瑞马唑仑在儿童无痛胃镜检查中的应用[J].临床与病理杂志,2021,41(12):2918-2922.
[11] 白雪,罗昊,黄雅莹,等.甲苯磺酸瑞马唑仑与丙泊酚在儿童无痛胃镜检查中的比较[J].实用医学杂志,2023,39(19): 2529-2533.
[12] 张彤彤,邢飞,李岩,等.瑞马唑仑复合丙泊酚用于患儿门诊根管治疗术镇静的效果[J].中华麻醉学杂志,2022,42(2): 213-216.
[13] Horikoshi Y, Kuratani N, Tateno K, et al. Anesthetic management with remimazolam for a pediatric patient with Duchenne muscular dystrophy[J].Medicine (Baltimore), 2021,100(49):e28209.
[14] Kiyokawa M, Saito J, Nakai K, et al. A remimazolam and remifentanil anesthetic for a pediatric patient with a medium-chain Acyl-CoA dehydrogenase deficiency: a case report[J].A A Pract, 2022,16(12):e01646.
[15] Petkus H, Willer BL, Tobias JD. Remimazolam in a pediatric patient with a suspected family history of malignant hyperthermia[J].J Med Cases, 2022,13(8):386-390.
[16] 陈红芽,王惠军,奚春花,等.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比较[J].中华医学杂志,2024,(29):2728-2733.
[17] Lee TY, Kim MA, Eom DW, et al. Comparison of remimazolam-remifentanil and propofol-remifentanil during laparoscopic cholecystectomy[J].Anesth Pain Med (Seoul), 2023,18(3):252-259.
[18] Luo Z, Cao H, Luo L, et al. Comparison of remimazolam tosilate and propofol during induction and maintenance of general anesthesia in patients undergoing laparoscopic cholecystectomy: a prospective, single center, randomized controlled trial[J].BMC anesthesiology, 2024,24(1):226.
[19] Shen Y, Sun Y, Wang YT, et al. Dose equivalence of remimazolam and propofol for loss of consciousness in pediatric patients: a randomized clinical trial[J].Pain Physician, 2024,27(8):521-528.
[20] Hosokawa M, Takahashi Y, Ueno T, et al. Remimazolam anesthesia in pediatric patients undergoing cardiac catheterization for congenital heart disease: a retrospective observational study[J].J Anesth, 2024,38(6):796-805.
[21] Fang YB, Wang CY, Gao YQ, et al. The safety and efficacy of remimazolam tosylate for induction and maintenance of general anesthesia in pediatric patients undergoing elective surgery: Study protocol for a multicenter, randomized, single-blind, positive-controlled clinical trial[J].Front Pharmacol, 2023,14:1090608.
[22] Eisenried A, Schüttler J, Lerch M, et al. Pharmacokinetics and pharmacodynamics of remimazolam (CNS 7056) after continuous infusion in healthy male volunteers: Part Ⅱ. Pharmacodynamics of electroencephalogram effects[J].Anesthesiology, 2020,132(4):652-666.
[23] Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale[J].Anesthesiology, 2004,100(5):1138-1145.
[24] Doi M, Morita K, Takeda J, et al. Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase Ⅱb/Ⅲ trial[J].J Anesth, 2020,34(4):543-553.
[25] Gao YQ, Ihmsen H, Hu ZY, et al. Pharmacokinetics of remimazolam after intravenous infusion in anaesthetised children[J].Br J Anaesth, 2023,131(5):914-920.
[26] Fang YB, Zhong JW, Szmuk P, et al. Safety and efficacy of remimazolam tosilate for general anaesthesia in paediatric patients undergoing elective surgery: a multicentre, randomised, single-blind, controlled trial[J].Anaesthesia, 2025,80(3):259-268.
[27] Peng X, Liu C, Zhu Y, et al. Hemodynamic influences of remimazolam versus propofol during the induction period of general anesthesia: a systematic review and meta-analysis of randomized controlled trials[J].Pain Physician, 2023,26(7):E761-E773.
[28] Ebert TJ. Sympathetic and hemodynamic effects of moderate and deep sedation with propofol in humans[J].Anesthesiology, 2005,103(1):20-24.
[29] Hasegawa G, Hirata N, Yoshikawa Y, et al. Differential effects of remimazolam and propofol on heart rate variability during anesthesia induction[J].J Anesth, 2022,36(2):239-245.
[30] Lan H, Cao H, Liu S, et al. Efficacy of remimazolam tosilate versus propofol for total intravenous anaesthesia in urological surgery: a randomised clinical trial[J].Eur J Anaesthesiol, 2024,41(3):208-216.
[31] 付韩菡.瑞马唑仑与丙泊酚应用于儿童影像学检查时镇静效果比较[J].山东第一医科大学(山东省医学科学院)学报,2024,45(11):669-672.
[32] Zhang X, Li S, Liu J. Efficacy and safety of remimazolam besylate versus propofol during hysteroscopy: single-centre randomized controlled trial[J].BMC Anesthesiology,2021,21(1):156.
[33] Lu L, Chen B, Zhao X, et al. Comparison of remimazolam and propofol in recovery of elderly outpatients undergoing gastrointestinal endoscopy: a randomized, non-inferiority trial[J].Drug Des Devel Ther, 2024,18:4307-4318.
[34] Chu T, Zhou S, Wan Y, et al. Comparison of remimazolam and propofol combined with low dose esketamine for pediatric same-day painless bidirectional endoscopy: a randomized, controlled clinical trial[J].Front Pharmacol, 2024,15:1298409.
/
| 〈 |
|
〉 |