Table 3.

Main Clinical Trials of Remimazolam for Sedation Undergoing Colonoscopy

Author (Year)	Phase	N	Dose of Remimazolam	Age (Years)	Primary Endpoint	Comparator	Co-Treatment	Location (s)	Results
Rex et al 201841	III	461	5.0 mg plus 2.5 top-ups	18–74	Efficacy and safety of remimazolam in patients undergoing colonoscopy	Midazolam [1.75 mg plus 0.5 mg (≥60 years) or 1.0 mg (<60 years) top-ups]	Fentanyl (75 μg)	USA	Patients in remimazolam group had Procedural success rate, faster mean procedure time and recovery time, less needed of fentanyl, less incidence of hypotension
Liu et al 202142	III	260	0.15mg/kg plus 0.075 mg/kg top-ups	65–75	Efficacy and safety of remimazolam in elderly outpatients undergoing colonoscopy	Etomidate-Propofol (0.1 mL/kg plus 0.05 mL/kg top-ups)	Fentanyl (0.15 mg/kg plus 0.5 mg/kg top-ups, the maximum dose of 150 μg)	China	The procedure success rate in remimazolam group was non-inferior to etomidate-propofol group (96.52% vs 100.00%; difference in rate −3.48%, 95% CI −6.81% to −0.15%), and has a higher safety for elderly patients
Rex et al 202143	III	79	2.5–5.0 mg plus 1.25–2.5 mg top-ups	42–84	Safety and efficacy of remimazolam in ASA class III/IV patients undergoing colonoscopy	Midazolam (1.0 mg plus 0.5 mg top-ups)	Fentanyl (50 μg, top up doses of 25 μg, the maximum dose of 200 μg)	USA	Procedure success for patients treated with remimazolam, placebo, midazolam was 87.1%, 0%, 13.3%, the shorter time to sedation and recovery in remimazolam group, and no serious AEs were reported. it can be efficacy and safety for sedation in ASA III/IV patients
Yao et al 202244	III	132	0.2 mg/kg plus 6 mg top-ups	18–65	Discharge readiness after remimazolam versus propofol for colonoscopy	Propofol (1 mg/kg plus 30 mg top-ups)	Sufentanil (5 mg)	China	Remimazolam provided a similar sedative efficacy and safer profile in patients undergoing colonoscopy, compared with propofol

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