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. 2021 Jul 20;12:690875. doi: 10.3389/fphar.2021.690875

TABLE 3.

Published clinical trials of remimazolam in procedural sedation. NA = not available/applicable, GI = gastrointestinal. N = number of patients.

Trial ID Procedure Phase ASA class N Primary endpoint Salt form Dose Co-treatment Comparator Ref
NCT00869440 Upper GI endoscopy II I - II 100 Success of procedure Besylate 0.1–0.2 mg/kg NA Midazolam Borkett et al. (2015)
NCT01145222 Colonoscopy II I - III 162 Success of procedure Besylate 5–8 mg plus 2–3 mg top-ups Fentanyl Midazolam Pambianco et al. (2016)
NCT02290873 Colonoscopy III I - III 461 Success of procedure Besylate 5 mg plus 2.5 mg top-ups Fentanyl Midazolam, placebo Rex et al. (2018)
NCT02296892 Bronchoscopy III I - III 446 Success of procedure Besylate 5 mg plus 2.5 mg top-ups Fentanyl Midazolam, placebo Pastis et al. (2019)
NCT02532647 Colonoscopy III III-IV 79 Success of procedure Besylate 2.5–5.0 mg plus 1.25–2.5 mg top-ups Fentanyl Midazolam, placebo Rex et al. (2021)
NCT03779061 Colonoscopy III I - II 384 Successful sedation Tosylate 5 mg plus 2.5 mg top-ups Fentanyl Propofol Chen et al., (2020a)
NCT03425474 Upper GI endoscopy III I - II 384 Successful sedation Tosylate 5 mg plus 2.5 mg top-ups Fentanyl Propofol Chen et al. (2021)
ChiCTR-2000038252 Hysteroscopy II I-II 82 Adverse events Besylate 0.2 mg/kg/min then 1 mg/kg/h Remifentanil Propofol Zhang et al. (2021)