Safety and efficacy of remimazolam tosilate for general anaesthesia in paediatric patients undergoing elective surgery: a multicentre, randomised, single-blind, controlled trial

Yu-Bo Fang; John Wei Zhong; Peter Szmuk; Yun-Long Lyu; Ying Xu; Shuangquan Qu; Zhen Du; Wangning Shangguan; Hua-Cheng Liu

doi:10.1111/anae.16475

Safety and efficacy of remimazolam tosilate for general anaesthesia in paediatric patients undergoing elective surgery: a multicentre, randomised, single-blind, controlled trial

Anaesthesia. 2024 Nov 22. doi: 10.1111/anae.16475. Online ahead of print.

Authors

Yu-Bo Fang^{1

2}, John Wei Zhong^{3

4}, Peter Szmuk^{3

4}, Yun-Long Lyu^{1

2}, Ying Xu^{5

6}, Shuangquan Qu⁷, Zhen Du⁷, Wangning Shangguan^{1

2}, Hua-Cheng Liu^{1

2}

Affiliations

¹ Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.
² Key Laboratory of Paediatric Anaesthesiology, Ministry of Education, Wenzhou Medical University, Wenzhou, Zhejiang, China.
³ Department of Anaesthesiology and Pain Management, University of Texas Southwestern Medical Centre, Dallas, TX, USA.
⁴ Outcome Research Consortium, Cleveland, OH, USA.
⁵ Department of Anaesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.
⁶ National Clinical Research Centre for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, China.
⁷ Department of Anaesthesiology, Hunan Children's Hospital, Changsha, Hunan, China.

PMID: 39577009
DOI: 10.1111/anae.16475

Abstract

Introduction: Remimazolam is an ultra-short-acting benzodiazepine sedative drug. This study aimed to compare the efficacy and safety of remimazolam with propofol for induction and maintenance of general anaesthesia in children undergoing elective surgery.

Methods: Children (aged 3-6 y, ASA physical status 1 or 2, BMI 14-25 kg.m^-2) undergoing elective surgery under general anaesthesia with tracheal intubation were eligible for inclusion. Children were allocated randomly using a web-based system to receive either remimazolam or propofol in a 3:1 ratio. After receiving fentanyl 3 μg.kg^-1, children received their allocated drug for both induction and maintenance of general anaesthesia. Induction doses were remimazolam 0.3 mg.kg^-1 or propofol 2.5 mg.kg^-1, with a second dose given should they not achieve loss of consciousness. After neuromuscular blockade and tracheal intubation, maintenance anaesthesia was achieved with an infusion either remimazolam 1-3 mg.kg^-1.h^-1 or propofol 4-12 mg.kg^-1.h^-1, alongside a remifentanil infusion (0.1-0.5 μg.kg^-1.min^-1) titrated to surgical stimulus and haemodynamic parameters. Primary outcomes were the incidence of successful induction and maintenance of anaesthesia. Secondary outcomes included: time to loss of consciousness, awakening and tracheal extubation; incidence of emergence delirium and moderate or severe pain in post-anaesthesia care unit; incidence of negative behaviour change after surgery at postoperative day 3; and incidence of adverse events.

Results: A total of 187 children were analysed (140 allocated to remimazolam and 47 to propofol). All children achieved successful induction of anaesthesia. Successful maintenance of anaesthesia was achieved in 139 (99%) children who received remimazolam compared with 46 (98%) who received propofol (rate difference 1.4%, 95%CI -2.9-5.8%, p = 0.441). Adverse events occurred in 27 (19%) children who received remimazolam and 23 (49%) who received propofol.

Discussion: Remimazolam was well tolerated for the induction and maintenance of general anaesthesia in pre-school-age children and was non-inferior to propofol.

Keywords: efficacy; general anaesthesia; paediatric patients; propofol; remimazolam.

Abstract

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