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Tests treatment safety and results for Effect of Drug
Official title Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation
ClinicalTrials.gov ID: NCT06575530
What this study is testing
What is Remimazolam Besylate?
Remimazolam Besylate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for effect of drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.