Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 306
- Locations
- 2
- Primary Endpoint
- Percentage of time in optimal sedation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged between 18 and 64 years
- •Scheduled to undergo elective non-cardiac surgery
- •Planned for general anesthesia
- •With or without combined regional nerve blockade
- •Admitted to the ICU with endotracheal intubation post-surgery
- •With an anticipated duration of postoperative mechanical ventilation greater than 24 hours
- •Clinically requiring light sedation( target RASS score 0 to -2)
Exclusion Criteria
- •Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases
- •Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease
- •Inability to communicate preoperatively due to coma, severe dementia, or language barriers
- •Preoperative .cardiac insufficiency or severe cardiac arrhythmias
- •Severe hepatic impariment( Child-Pugh class C)
- •Severe renal impariment
- •Preoperative( within 24 hours prior to surgery) or intraoperative administration of dexmedetomidine or remimazolam
- •Pregnancy or lactation
- •Participation in any clinical trial involving investigational drugs within 30 days prior to enrollment
- •Any other conditions deemed by the investigators to render the patient unsuitable for study participation
- •Refusal to provide written informed consent
Arms & Interventions
Dexmedetomidine hydrochloride group
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.
Intervention: Dexmedetomidine Hydrochloride (Drug)
remimazolam besylate group
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.
Intervention: Remimazolam Besylate (Drug)
Outcomes
Primary Outcomes
Percentage of time in optimal sedation
Time Frame: Through the useage of sedative drugs in the ICU, an average of 3 days
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.
Secondary Outcomes
- Ventilation free days(Through the initiation of enrollment to 28 days, an average of 1 day)
- Dosage of rescue sedatives(Through the useage of sedative drugs in the ICU, an average of 3 days)
- Frequency of rescue sedatives(Through the useage of sedative drugs in the ICU, an average of 3 days)
- post-sedation extubation time(From ICU admission to extubation, an average of 3 days)
- Proportion of different oxygen therapies post-extubation(Through the ICU stay, an average of 3 days)
- Pain scores during the first 3 postoperative days(The first 3 days of ICU stay, an average of 3 days)
- Sleep quality scores on the day of ICU discharge(The day transfer out of ICU, an average of 1day)
- Cognitive assessment scores on postoperative day 60(Day 60 after surgery, an average of 1 day)
- Sleep quality scores on postoperative day 60(Day 60 after surgery, an average of 1 day)
- Postoperative hospital LOS(The day the patient discharge, an average of 1 day)
- 60-day all-cause mortality(Day 60 postoperative, an average of 1 day)
- 60-day non-neurological complications(Day 60 postoperative, an average of 1 day)
- Delirium incidence(Through the ICU stay, an average of 3 days)
- Re-mechanical ventilation incidence after weaning and extubation(Through the ICU stay, an average of 3 days)
- ICU LOS(The day the patient transfer out of ICU, an average of 1 day)