November 29, 2025
Background: Remimazolam is an ultra-short-acting benzodiazepine sedative. This study compared the efficacy and safety of remimazolam with propofol for the induction and maintenance of general anesthesia in children undergoing elective surgery.
Methods: Children aged 3-6 years with American Society of Anesthesiologists (ASA) physical status I or II and body mass index (BMI) of 14-25 kg/m² undergoing elective surgery with tracheal intubation were randomized in a 3:1 ratio to receive either remimazolam or propofol. Following fentanyl 3 μg/kg, anesthesia was induced with remimazolam 0.3 mg/kg or propofol 2.5 mg/kg, with a second dose administered if loss of consciousness was not achieved. After neuromuscular blockade and tracheal intubation, anesthesia was maintained with remimazolam (1-3 mg/kg/h) or propofol (4-12 mg/kg/h), together with remifentanil (0.1-0.5 μg/kg/min). The primary outcomes were successful induction and maintenance of anesthesia. Secondary outcomes included time to loss of consciousness, awakening, and tracheal extubation; incidence of emergence delirium; moderate or severe postoperative pain; negative behavioral changes on postoperative day 3; and adverse events.
Results: A total of 187 children were analyzed, including 140 in the remimazolam group and 47 in the propofol group. Successful induction of anesthesia was achieved in all children. Successful maintenance of anesthesia occurred in 139 of 140 children (99%) receiving remimazolam and 46 of 47 children (98%) receiving propofol (rate difference 1.4%; 95% confidence interval -2.9% to 5.8%; P = 0.441). Adverse events occurred in 27 children (19%) in the remimazolam group compared with 23 children (49%) in the propofol group.
Conclusions: Remimazolam was as effective as propofol for the induction and maintenance of general anesthesia in children aged 3-6 years undergoing elective surgery, while being associated with a lower incidence of adverse events.
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