Remimazolam Besylate in Sedation of Postcardioperative Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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 criteria

Qualifiers

age ≥ 18 years ;

admitted to the intensive care unit after cardiac surgery with techanical ventilation;

expected to extubation within 48hours ;

participant has given informed consent

Disqualifiers

pregnant or lactating women

known or suspected hypersensitivity to the study drug

history of impaired consciousness or psychiatric illness

severe bradycardia with a heart rate of < 50 beats per minute

Trial design

Treatments tested in this trial

  • Remimazolam
  • Propofol

Treatment groups

120 Participants
are divided into 2 treatment groups