A randomized non-inferior trial comparing remimazolam besylate with propofol for long-term sedation during invasive mechanical ventilation in critically ill patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
728
Sedation drug
Propofol. Sedation drug
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
RECRUITINGThe percentage of time in the target sedation range without rescue sedation
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are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Invasive ventilator free time
Hours of time free from invasive ventilator
Time frame: From start of study to 7 days
Successful extubation rate
Extubation of endotracheal tube for the first time in 7 days without reintubation or switching to tracheostomy within the following 48 hours
Time frame: From start of study to 7 days
Length of ICU stay
Length of ICU stay
Time frame: From start of study to 28 days
Mortality
Mortality
Time frame: From start of study to 28 days
Length of hospitalization
Length of hospitalization
Time frame: From start of study to 28 days
weaning time
weaning time in minutes between continuous discontinuation of the study drug and extubation in patients with successful extubation
Time frame: From start of study to 7 days
Rate of hypotension
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Systolic blood pressure less than 80 mmHg or diastolic blood pressure less than 50 mmHg for 5 minutes or treated with vasopressors
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are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of hypertension
systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mmHg for 5 minutes or treated with vasodilators
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are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of bradycardia
heart rate less than 50 bpm for 5 minutes or treated with medication to increase heart rate
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
Rate of tachycardia
heart rate greater than 120 bpm for 5 minutes or treated with medication to decrease heart rate
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
Rate of unplanned extubation of endotracheal tube
unplanned extubation of endotracheal tube
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
Rate of shock
New-onset shock
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
Rate of hospital-acquired pneumonia
hospital-acquired pneumonia
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
Rate of myocardial infarction
myocardial infarction
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
Rate of cerebral ischemic stroke
cerebral ischemic stroke
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
Rate of cerebral hemorrhagic stroke
Rate of cerebral hemorrhagic stroke
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
Rate of pulmonary embolism
pulmonary embolism
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
Rate of upper digestive tract ulcer confirmed endoscopically
upper digestive tract ulcer confirmed endoscopically
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
Rate of more than 500 milliliters of bloody stool
more than 500 milliliters of bloody stool
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
Rate of delirium
delirium
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
delta SOFA
defined as the difference between SOFA when each patient stops receiving the study drug and SOFA at inclusion
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
Rate of withdraw from the trial because of intolerance, severe adverse events or other safety concerns
rate of withdraw from the trial because of intolerance, severe adverse events or other safety concerns
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