Comparative Clinical Study of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgery Under General Anaesthesia
Condition: General Anaesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to perform comparative evaluation of clinical efficacy and
      safety of Remimazolam and Propofol for induction and maintenance of general anesthesia in
      patients undergoing elective surgery under general anaesthesia.
    

Detailed description: 
      Only patients with scheduled operations were screened for eligibility in this study.
      Screening period for each patient lasted from 1 to 14 days. All patients eligible as per
      protocol criteria were randomized in 1:1 ratio to receive investigational or reference drug.
      Randomisation was carried out in admission to the operating room - Day1.

      For the induction of anesthesia, first there was administration of the trial drug / reference
      drug, then - administration of a narcotic analgesic (fentanyl at a dose of 2 mg/kg), after
      which after loss of consciousness, muscle relaxant was used (rocuronium bromide at a dose of
      0.6-0.9 mg/kg). Tracheal intubation was performed after achieving the necessary relaxation of
      the muscles.

      Maintenance of anesthesia during surgery was done using the trial drug / reference drug,
      muscle relaxant (rocuronium bromide - if necessary, during the anesthesia maintenance, the
      dose was selected individually) and narcotic analgetic (fentanyl, if necessary, during the
      anesthesia maintenance, the dose was selected individually). To control patient's condition
      before, during and after surgery, the significant vital parameters were monitored (level of
      blood pressure and heart rate, respiratory rate, body temperature, saturation, intraoperative
      ECG, bispectral index (BIS)).

      After the operation patients were transferred to the postoperation room where the assessment
      of the operation memory, and possible presence of postoperative delirium was performed as
      well as on Day 2. Further treatment and determination of compliance of patient's condition
      with the criteria for discharge from the hospital was carried out in accordance with current
      practice of the center.

      In 7 (± 2) days after the end of trial drugs administration, patient's condition monitoring
      and safety evaluation were carried out through telephone contact with the patient, during
      which data on adverse events and concomitant therapy were collected. Scheduled trial duration
      for each patient was a maximum of 24 days.

      Therapy was considered ineffective, if other sedatives were required for induction (loss of
      consciousness was not registered after study drugs dose adjustment) and/or maintenance of the
      required level of sedation during anesthesia (in case of signs of awakening appeared and
      remained after study drugs dose adjustment).

      Therapy efficacy evaluation was based on primary and secondary efficacy criteria. Effect of
      general anesthetic, a combined evaluation criterion consisted of the following criteria. The
      trial drug/reference drug was regarded effective in patients who had not had any of the below
      criteria and ineffective in patients who had at least one of the below criteria:

        1. Intraoperative awakening / preservation of memories of operations;

        2. The need for additional sedation.
    

Intervention name(s): Remimazolam; Propofol; Fentanyl; Rocuronium bromide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lyophilisate for preparation of solution for intravenous administration, 50 mg. Required to prepare a 50 ml syringe with the infusion solution at a concentration of 1 mg/ml (in accordance with guidance given in protocol); Emulsion for infusion, 10 mg/mL in 20-mL glass vials; Solution for intravenous administration, 50 mg/mL. Used for anesthesia induction (at a dose of 2 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually); Solution for intravenous administration, 10 mg/mL. Used for anesthesia induction (at a dose of 0.6-0.9 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually)
Other intervention name(s): Diprivan®
Intervention MeSH terms: Fentanyl; Bromides; Propofol; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: anaesthesia; surgery