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

Table 4.

Main Clinical Trials of Remimazolam for Sedation Under Bronchoscopy

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.