Remimazolam Besylate in Sedation of Postcardioperative Patients
Recruiting now · Not applicable
Conditions studied: Remimazolam, Propofol, Sedation, Mechanical Ventilation, Intensive Care, Cardiac Surgery
In brief
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.
Key facts
- Study ID
- NCT06716840
- Run by
- First Affiliated Hospital of Zhejiang University
- People needed
- 120
- Starts
- 2025-02-10
- Expected to finish
- 2025-05-31
- Last updated by the study team
- 2025-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- systolic blood pressure < 90 mmHg with fluid resuscitation and vasopressor maintenance
- atrioventricular block（II or III degree）, Left ventricular ejection fraction(LVEF) <30%
- participated in other clinical studies within 3 months
Where it is running
- First afflilated hospital of zhejiang university school of medicine — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.