A Randomized, Single-blind Phase II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follow-up Sedation in the PACU/ICU
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Paion UK Ltd.
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Proportion of patients with successful anesthesia
Study Overview
Brief Summary
This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general anesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •scheduled for major elective cardiac surgery.
- •scheduled for mechanical ventilation via tracheal intubation.
Exclusion Criteria
- •thoraco-abdominal replacement of the aorta or other procedure expected to be accompanied by a massive hemorrhage (at least 15% of the circulating blood volume).
Arms & Interventions
Propofol
Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Intervention: Propofol (Drug)
Propofol
Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Intervention: Sevoflurane (Drug)
Propofol
Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Intervention: Remifentanil (Drug)
Propofol
Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Intervention: Fentanyl (Drug)
Propofol
Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Intervention: Rocuronium (Drug)
Remimazolam 6 mg/kg/hr
Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Intervention: Remimazolam (Drug)
Remimazolam 6 mg/kg/hr
Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Intervention: Remifentanil (Drug)
Remimazolam 6 mg/kg/hr
Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Intervention: Fentanyl (Drug)
Remimazolam 6 mg/kg/hr
Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Intervention: Rocuronium (Drug)
Remimazolam 12 mg/kg/hr
Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Intervention: Remimazolam (Drug)
Remimazolam 12 mg/kg/hr
Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Intervention: Remifentanil (Drug)
Remimazolam 12 mg/kg/hr
Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Intervention: Fentanyl (Drug)
Remimazolam 12 mg/kg/hr
Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Intervention: Rocuronium (Drug)
Outcomes
Primary Outcomes
Proportion of patients with successful anesthesia
Time Frame: Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)
Successful anesthesia was defined as no use of rescue sedative medication between start of the study medication and end of the surgical procedure completion of last skin suture.
Secondary Outcomes
No secondary outcomes reported