NCT05555667RecruitingPhase 3
Long-term Sedation With Remimazolam Besylate Versus Propofol in Critically Ill Patients During Invasive Mechanical Ventilation: a Randomized Non-inferior Trial
Wuhan Union Hospital, China1 site in 1 country728 target enrollmentStarted: May 16, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 728
- Locations
- 1
- Primary Endpoint
- The percentage of time in the target sedation range without rescue sedation
Study Overview
Brief Summary
A randomized non-inferior trial comparing remimazolam besylate with propofol for long-term sedation during invasive mechanical ventilation in critically ill patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 and ≤ 80 years;
- •Intubated and mechanically ventilated ≤96 hours before enrollment；
- •Expected to require continuous invasive ventilation and sedation ≥24 hours;
- •Requirement for light to moderate sedation (a RASS score of -3 to 0)
Exclusion Criteria
- •Body mass index (BMI) <18 or >30 kg/m2;
- •Allergy or unsuitabilty to any composition of study drugs or remifentanil;
- •Living expectancy less than 48 hours；
- •Possible surgey in the operating room in 24 hours；
- •Myasthenia gravis;
- •Serious hepatic dysfunction (CTP 10-15);
- •Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2;
- •Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
- •Acute severe neurological disorder and any other condition interfering with RASS assessment;
- •Pregnancy or lactation;
- •Unstable angina or acute myocardial infarction;
- •Left ventricular ejection fraction less than 30%;
- •Heart rate less than 50 beats/min;
- •Grade 2 , second degree or third degree atrioventricular block in the absence of a pacemaker;
- •Abuse of controlled substances or alcohol;
- •Other conditions deemed unsuitable to be included;
Arms & Interventions
Remimazolam besylate
Experimental
Remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted (maximum of 0.3 mg/kg/h) to maintain a RASS score between - 3 and 0
Intervention: Remimazolam besylate (Drug)
Propofol
Active Comparator
Propofol intravenously at an initial infusion rate of 2.0 mg/kg/h and adjusted (maximum of 4.0 mg/kg/h) to maintain a RASS score between - 3 and 0
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
The percentage of time in the target sedation range without rescue sedation
Time Frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
The percentage of time in the target sedation range without rescue sedation
Secondary Outcomes
- Invasive ventilator free time(From start of study to 7 days)
- Length of ICU stay(From start of study to 28 days)
- weaning time(From start of study to 7 days)
- Rate of hypertension(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of shock(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of cerebral ischemic stroke(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of upper digestive tract ulcer confirmed endoscopically(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of more than 500 milliliters of bloody stool(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of hypotension(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of bradycardia(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of tachycardia(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of hospital-acquired pneumonia(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- delta SOFA(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of unplanned extubation of endotracheal tube(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of delirium(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Successful extubation rate(From start of study to 7 days)
- Mortality(From start of study to 28 days)
- Length of hospitalization(From start of study to 28 days)
- Rate of withdraw from the trial because of intolerance, severe adverse events or other safety concerns(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of myocardial infarction(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of cerebral hemorrhagic stroke(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
- Rate of pulmonary embolism(7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first)
Investigators
Xiaobo Yang, MD
Clinical Professor
Wuhan Union Hospital, China
Study Sites (1)
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