Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients
Efficacy and Safety of Remazolam Besylate in Patients Requiring Mechanical Ventilation Admitted to ICU After Non-cardiac Surgery: Protocol for a Randomized, Controlled No-inferiority Trial
Beijing Shijitan Hospital, Capital Medical University
306 participants
Jan 20, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- years old
- must accept no-cardiac elective surgery
- must under general anaesthesia
- can be combined regional tissue anesthesia
- must admitted to ICU with tracheal intubation after general anaesthesia - expected mechanical ventilation time must more than 24 hours
- light or moderate sedation must needed
Exclusion Criteria10
- intracranial surgery or severe neurological or spinal cord disease
- schizophrenia, epilepsy, and Parkinson's disease
- coma, severe dementia, or language barrier before surgery
- cardiac dysfunction or arrhythmia
- severe liver dysfunction(Child-Pugh C class)
- severe kidney dysfunction
- use of dexmedetomidine or remifentanil besylate 24 hours before or during surgery
- pregnancy or lactation
- any investigational drug useage 30 days before surgery
- refuse to participant.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06575530