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Phase III Confirmatory Efficacy and Safety Trial of Remimazolam (CNS7056) Compared With Propofol for Intravenous Anesthesia During Elective Surgery in ASA Class III/IV Patients

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Trial Profile

Phase III Confirmatory Efficacy and Safety Trial of Remimazolam (CNS7056) Compared With Propofol for Intravenous Anesthesia During Elective Surgery in ASA Class III/IV Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2024

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At a glance

  • Drugs Remimazolam (Primary) ; Propofol; Remifentanil
  • Indications General anaesthesia
  • Focus Registrational; Therapeutic Use
  • Sponsors PAION

    • Most Recent Events

    • 14 Jan 2024 Primary endpoint has been met. (Percentage (%) of time of Narcotrend Index (NCI) values 60 during maintenance phase of general anesthesia (defined as time between the first skin incision and the completion of the last skin suture))
    • 14 Jan 2024 Results comparing the anaesthetic efficacy and the incidence of postinduction hypotension during total intravenous anaesthesia with remimazolam vs. Propofol, published in the Anaesthesia
    • 12 May 2021 According to a PAION media release, the marketing approval application (MAA) for Remimazolam for general anesthesia is expected until the end of 2021.
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