Table 5.

Main Clinical Trials of Remimazolam for Sedation in General Anesthesia

Author (Year)	Phase	N	Dose of remimazolam	Age (years)	Primary endpoint	Comparator	Co-treatment	Location (s)	Results
Doi et al 202049	IIb/III	391	Initial dose: 6 mg/kg/h or 12 mg/kg/h Maintenance dose: 1–2 mg/kg/h	≥ 20	Efficacy and safety	Propofol was started at 2.0–2.5 mg/kg, followed by 4–10 mg/kg/h	Remifentanil (0.25 and 0.5 μg/kg/min, maintained by 0.25–2.0 µg/kg/min)	Japan	Remimazolam showed well tolerated and non-inferior to propofol in term of efficacy as a sedative for general anesthesia, but the time to LoC, recovery, and extubation were both longer than propofol
Doi et al 202050	III	67	Initial dose: 6 mg/kg/h or 12 mg/kg/h Maintenance dose: 1–2 mg/kg/h	≥ 20	Efficacy and safety	N/A	N/A	Japan	Remimazolam could be used safely and effectively in high-risk surgical patients (ASA Class III), time to LoC was significantly shorter with dose of 12 mg/kg/h
Chae et al 202251	III	120	Six dose groups of 0.02, 0.07, 0.12, 0.17, 0.22, and 0.27 mg/kg	>18	Determine the ED50 and ED95 Of IV remimazolam for LoC	N/A	N/A	Korea	A bolus injection of remimazolam can be administered safely without causing significant hemodynamic instability. The optimal doses of 0.25–0.33, 0.19–0.25, and 0.14–0.19 mg. kg-1 in 95% patients aged <40, 60–80, and >80 years
Shimamoto et al 202252	N/A	76	Initial dose: 0.2 mg/kg Maintenance dose: 1–2mg/kg/h	20–80	Efficacy and safety	Propofol was started at 2 mg/kg, followed by 4–10 mg/kg/h	Fentanyl citrate (3 μg/kg, maintained by remifentanil 0.25 µg/kg/min)	China	Remimazolam tosilate can provide satisfactory anesthetic effects for EVL and combination with flumazenil can induce quick recovery from anesthesia

Abbreviations: N, number of subjects; N/A, not available/applicable.