TABLE 3.
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) |