Remimazolam Besylate in Sedation of Postcardioperative Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Remimazolam: participants in the remimazolam group received remimazolam besylate intravenously at an initial infusion rate of 0.2mg/kg/h and adjusted (maximum of 2 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale(RASS) score between - 2 and 0.If the maximum dose of remimazolam was insufficient to sedate, add rescue dexmedetomidine.

Propofol: participants in the propofol group received propofol intravenously at an initial infusion rate of 1 mg/kg/h and adjusted (maximum of 4 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale (RASS) score between - 2 and 0.If the maximum dose of propofol was insufficient to sedate, add rescue dexmedetomidine.

Study summary

Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation，in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (\> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finally，the investigators will compare the sedation effect and safety between the 2 groups ，to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.

Eligibility

Primary outcome measure(s)

• percentage of time in the target sedation range — up to 2 days
  The primary outcome was the percentage of time in the target sedation range without rescue sedation.

Trial sites (1)

More First Affiliated Hospital of Zhejiang University trials in China

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