A Phase 4 interventional study of Remimazolam Besylate and Dexmedetomidine Hydrochloride in Effect of Drug, Adverse Drug Event and Mechanical Ventilation Complication, sponsored by Beijing Shijitan Hospital, Capital Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Beijing Shijitan Hospital, Capital Medical University · Phase 4, Interventional, and Treatment
A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.
437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.
This study's planned enrollment of 306 is above the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →Beijing Shijitan Hospital, Capital Medical University is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Upon ICU admission, remimazolam besylate infusion will initiated for light sedation maintenance at a dose range of 0.1 to1.0mg/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of remimazolam besylate will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less.
Drug: Remimazolam Besylate
Upon ICU admission, dexmedetomidine infusion will initiated for light sedation maintenance at a dose range of 0.2 to0.7ug/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of dexmedetomidine will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less.
Drug: Dexmedetomidine Hydrochloride
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. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections of propofol. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.
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. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.
Percentage of time in optimal sedation
Percentage of time in optimal sedation during sedation in the ICU, sedation depth is assessed using Richmond Agitation Sedation Scale(RASS, -5 to +4), target 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
Ventilation 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，if the patient is reintubated within 28 days, "X" represents the days of the last extubation; 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 rescue sedatives
Dosage of rescue 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 rescue sedatives
Frequency of rescue 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
post-sedation extubation time
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 post-extubation
Proportion of different oxygen therapies post-extubation
Time frame: Through the ICU stay, an average of 3 days
Pain scores during the first 3 postoperative days
Pain scores during the first 3 postoperative days, 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 scores on the day of ICU discharge
Sleep quality scores on the day of ICU discharge, 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 scores on postoperative day 60
Cognitive assessment scores on postoperative day 60, 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 scores on postoperative day 60
Sleep quality scores on postoperative day 60 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
Postoperative hospital LOS
postoperative hospital length of stay
Time frame: The day the patient discharge, an average of 1 day
60-day all-cause mortality
60-day all-cause mortality
Time frame: Day 60 postoperative, an average of 1 day
60-day non-neurological complications
60-day non-neurological complications
Time frame: Day 60 postoperative, an average of 1 day
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Drug-Related Side Effects and Adverse Reactions→
Beijing Shijitan Hospital, Capital Medical University