Recruiting NCT06575530
Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam Besylate, Dexmedetomidine Hydrochloride.
- Who it may be relevant to
- Registry conditions: Effect of Drug, Adverse Drug Event, Mechanical Ventilation Complication, Critical Illness. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Remimazolam Besylate
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 wil - Drug Dexmedetomidine Hydrochloride
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
Primary outcome measures
- Percentage of time in optimal sedation [Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days]
Secondary outcome measures (12)
- Ventilation free days [Time frame: Through the initiation of enrollment to 28 days, an average of 1 day]
- Dosage of rescue sedatives [Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days]
- Frequency of rescue sedatives [Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days]
- Delirium incidence [Time frame: Through the ICU stay, an average of 3 days]
- post-sedation extubation time [Time frame: From ICU admission to extubation, an average of 3 days]
- 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 [Time frame: Through the ICU stay, an average of 3 days]
- Pain scores during the first 3 postoperative days [Time frame: The first 3 days of ICU stay, an average of 3 days]
- Sleep quality scores on the day of ICU discharge [Time frame: The day transfer out of ICU, an average of 1day]
- Cognitive assessment scores on postoperative day 60 [Time frame: Day 60 after surgery, an average of 1 day]
- Sleep quality scores on postoperative day 60 [Time frame: Day 60 after surgery, an average of 1 day]
- ICU LOS [Time frame: The day the patient transfer out of ICU, an average of 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Shijitan Hospital.CMU — Beijing
Identifiers
NCT: NCT06575530 · IIT2024-001-002