Table 4.
Author (Year) | Phase | N | Dose of Remimazolam | Age (Years) | Primary Endpoint | Comparator | Co-Treatment | Location (s) | Results |
---|---|---|---|---|---|---|---|---|---|
Pastis et al 201945 | III | 446 | 5.0 mg plus 2.5 top-ups | ≥18 | Safety and efficacy for moderate sedation during bronchoscopy | Midazolam (1–1.75 mg plus 0.5–1.0 mg top-ups) |
Fentanyl (25–75 mg, top-up doses of 25 μg, the maximum dose of 200 μg) |
USA | Remimazolam achieved moderate procedural sedation efficacy and safety during flexible bronchoscopy, with a rapid onset and rapid return of cognitive function |
Jia et al 202146 | III | 50 | The first patient was given a dose of 0.18 mg/kg, Maintenance dose: 1mg/kg/h | 18–65 | Observation of effective dosage of remimazolam tosilate used for moderate sedation in bronchoscopy | N/A | Sufentanil (0.1 μg/kg); 2% lidocaine (5 mL, airway nebulization); flumazenil (0.2 mg) |
China | The ED50 and the ED95 of remimazolam tosilate for moderate sedation in bronchoscopy were 0.174 mg/kg and 0.219 mg/kg, combined with Sufentanil 0.1 μg/kg |
Chen et al 202247 | III | 146 | Initial dose: 12 mg/kg Maintenance dose: 1–2mg/kg/h | 45–65 | Efficacy and safety of remimazolam tosilate in patients undergoing bronchoscopy | Dexmedeto-midine (0.5 μg/kg, maintained by 0.2–0.7 μg/kg) | Remifentanil (0.05–0.2 μg/kg/min) |
China | Remimazolam tosilate has non-inferior efficacy, better time metrics and hemodynamic stability than dexmedetomidine combine with remifentanil in outpatients undergoing bronchoscopy |
Abbreviations: N, number of subjects; N/A, not available/applicable.