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. 2022 Nov 15;16:3957–3974. doi: 10.2147/DDDT.S384155

Table 2.

Main Clinical Trials of Remimazolam for Sedation Under Gastroscopy

Author (Year) Phase N Dose of Remimazolam Age (Years) Primary Endpoint Comparator Co-Treatment Location (s) Results
Borkett et al 201937 IIa 100 Three dose of group: 0.10, 0.15, or 0.20 mg/kg 18–65 Safety and efficacy of different single doses for sedation in upper gastrointestinal endoscopy Midazolam
0.075 mg/kg
N/A USA A single dose of remimazolam (0.1–0.2mg/kg) was able to induce rapider sedation and faster recovery than midazolam in patients undergoing upper gastrointestinal endoscopy
Chen et al 202138 III 384 5.0 mg plus 2.5 top-ups 18–60 Compare efficacy and safety of remimazolam tosilate with propofol for sedation in upper gastrointestinal endoscopy Propofol 1.5 mg plus 0.5 mg/kg top-ups Fentanyl
(0.5 μg/kg);
lidocaine viscous oral liquid 10g
China The sedation successful rate in remimazolam was non-inferior to propofol but shorter time to recovery from sedation, safety profile appears to be superior to propofol
Tan et al 202239 III 99 Initial dose: two dose of group (0.1 mg/kg or 0.2 mg/kg),
supplemental dose: 0.05 mg/kg
>60 Efficacy and safety of remimazolam tosilate in patients undergoing bronchoscopy Propofol 1.0–1.5 mg plus 0.5mg/kg top-ups N/A China A dose of 0.1 mg/kg remimazolam tosilate suitable for sedation in elderly patients undergoing upper gastrointestinal endoscopy
Cao et al 202240 III 148 0.107 mg/kg 18–65 Efficacy and safety of remimazolam tosilate sedation in patients with liver cirrhosis undergoing gastroscopy Propofol
2 mg/kg
Sufentanil 0.15 μg/kg China Remimazolam tosilate combined with sufentanil adjuvant is better than propofol with sufentanil in patients with liver cirrhosis undergoing gastroscopy

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