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

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) 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, children received their allocated drug for both induction and maintenance of general anaesthesia. Induction doses were remimazolam 0.3 mg.kg or propofol 2.5 mg.kg, 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.h or propofol 4-12 mg.kg.h, alongside a remifentanil infusion (0.1-0.5 μg.kg.min) 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.