A multi-center, prospective, randomized, double-blind, no-inferiority clinical trial designed to assess the the safety and efficacy of remazolam besylate in sedation of critically ill mechanically ventilated patients after surgery compared to dexmedetomidine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
306
patients will be sedated with remimazolam via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. A remedial sedation protocol will be initiated if remimazolam fails to achieve a satisfactory RASS score (0 to -2 points) within its upper dosage limits, propofol will be administered intravenously at a dose of 0.2 mg, followed by reassessment 5 minutes post-injection. The same dose of propofol will be repeated if the desired sedation depth is not reached. Continuous infusion of propofol will be started at a rate of 0.2 to 1 mg/kg/h if satisfactory sedation is not attained after three consecutive intravenous injections of propofol, the continuous infusion will be discontinued once the RASS score reaching the acceptable range (0 to -2).
patients will be sedated with dexmedetomidine hydrochloride via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. A remedial sedation protocol will be initiated if dexmedetomidine fails to achieve a satisfactory RASS score (0 to -2 points) within the upper dosage limits, propofol will be administered intravenously at a dose of 0.2 mg, followed by reassessment 5 minutes post-injection. The same dose of propofol will be repeated if the desired sedation depth is not reached. Continuous infusion of propofol will be started at a rate of 0.2 to 1 mg/kg/h if satisfactory sedation is not attained after three consecutive intravenous injections of propofol, the continuous infusion will be discontinued once the RASS score reaching the acceptable range (0 to -2).
Beijing Shijitan Hospital.CMU
Beijing, Beijing Municipality, China
RECRUITINGventilation free days
ventilation free days(VFDs) at 28 days. VFDs=0 if subject dies within 28 days of mechaincal ventilation; VFDs=28-X if successfully liberated from ventilation X days after initiation; VFDs=0 if the subject is mechaincally ventilated for \>28 days.
Time frame: Through the initiation of enrollment to 28 days, an average of 1 day
Dosage of remedial sedatives
Dosage of remedial sedatives during mechanical ventilation in the ICU
Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days
Frequency of remedial sedatives
Frequency of remedial sedatives during mechanical ventilation in the ICU
Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days
Delirium incidence
Delirium incidence during the patients' ICU stay, assessed using ConfusionAssessmentMethodfortheIntensive CareUnit(CAM-ICU, 4 items), delirium is diagnosed when 3 items are met
Time frame: Through the ICU stay, an average of 3 days
Proportional of predicted sedation time
Proportional of predicted sedation time during sedation time in the ICU, sedation depth is assessed using Richmond Agitation Sedation Scale(RASS, -5 to +4), predicted sedation must has a RASS score -2 to 0.
Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days
Extubation time after termination of sedation
Extubation time(hour) after termination of sedation
Time frame: From ICU admission to extubation, an average of 3 days
Re-mechanical ventilation incidence after weaning and extubation
Re-mechanical ventilation incidence after weaning and extubation
Time frame: Through the ICU stay, an average of 3 days
Proportion of different oxygen therapies after extubation
Proportion of different oxygen therapies after extubation
Time frame: Through the ICU stay, an average of 3 days
Pain assessment score the first 3 days after surgery
Pain assessment score the first 3 days after surgery, assessed using Critical-Care Pain Observation Tool(CPOT,0-8), the higher the score, the more painful the patient feels
Time frame: The first 3 days of ICU stay, an average of 3 days
Sleep quality score the day transfer out of ICU
Sleep quality score the day transfer out of ICU, assessed using St.Mary'sHospitalSleepQuestionnaire(SMHSQ, 11 to 55), the lower the score, the higher the degree of sleep disorders
Time frame: The day transfer out of ICU, an average of 1day
Cognitive assessment score 60 days after surgery
Cognitive assessment score 60 days after surgery, assessed using Telephone Interview for Cognitive Status-Modified(TICS-m,0-50), the higher the score, the better the cognitive function
Time frame: Day 60 after surgery, an average of 1 day
Sleep quality score 60 days after surgery
Sleep quality score 60 days after surgery, assessed using Pittsburgh sleep quality index(PSQI,0-21), the higher the score, the worse the sleep quality
Time frame: Day 60 after surgery, an average of 1 day
ICU LOS
ICU length of stay
Time frame: The day the patient transfer out of ICU, an average of 1 day
Hospital LOS after surgery
Hospital length of stay after surgery
Time frame: The day the patient discharge, an average of 1 day
All cause mortality 60 days after surgery
All cause mortality 60 days after surgery
Time frame: Day 60 after surgery, an average of 1 day
Non-neurological complications 60 days after surgery
Non-neurological complications 60 days after surgery
Time frame: Day 60 after surgery, an average of 1 day
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