Remimazolam Besylate in Sedation of Postcardioperative Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam, Propofol.
- Who it may be relevant to
- Registry conditions: Remimazolam, Propofol, Sedation, Mechanical Ventilation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Remimazolam Besylate Versus Propofolfor Sedation of Postcardioperative Patients in Intensive Care Unit: a Prospective,Single-center,Randomized Non-inferior Trial
Overview
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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- percentage of time in the target sedation range [Time frame: up to 2 days]
Secondary outcome measures (8)
- extubation time [Time frame: up to 2 days]
- extubation success rate [Time frame: up to 4 days]
- changes in blood pressure [Time frame: up to 2 days]
- changes in heart rate [Time frame: up to 2 days]
- ventilator-free days [Time frame: From enrollment to 7 days]
- the score of confusion assessment method for the intensive care unit ( CAM-ICU) [Time frame: From enrollment to the end of treatment at 28 days]
- stay length [Time frame: From enrollment to the end of treatment at 28 days]
- 28-day mortality [Time frame: From enrollment to the end of treatment at 28 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- First afflilated hospital of zhejiang university school of medicine — Hangzhou
Identifiers
NCT: NCT06716840 · 2024-143