RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxi… (NCT05606315) | Clinical Trial Compass
SuspendedPhase 4
RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery
Stopped: This study is temporarily suspended due to incomplete enrollment across multiple investigational sites. The recruitment process has not progressed as anticipated, resulting in insufficient participant numbers to support the primary analyses.
China117 participantsStarted 2022-03-16
Plain-language summary
Remimazolam besylate, as a new benzodiazepine drug, showing rapid clearance and moderate distribution of pharmacokinetic changes. The study will further explore the safety and effectiveness of remimazolam besylate n the sedation of mechanically ventilated patients after oral and maxillofacial surgery in the ICU.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years old;
* After undergoing oral and maxillofacial surgery, it is expected that a ventilator will be needed to assist with breathing;
* mechanical ventilation patients with expected ICU stay time \<72h;
* People who need immediate sedative treatment;
* Obtain informed consent from subject or legal representative;
Exclusion Criteria:
* Pregnancy；
* Can not get RASS score from patients;
* Allergy to drugs;
* Proven acute and severe intracranial or spinal nerve disease due to vascular, infection, intracranial dilation, or injury;
* Uncompensated acute circulatory failure at randomization (severe hypotension with MAP\<50 mmHg despite adequate fluid resuscitation and vasopressor therapy);
* Severe bradycardia (heart rate \<50 beats/min) or degree II-III heart block (unless a pacemaker is installed);
* A history of long-term use of benzodiazepines or opioids;
* Subjects receiving sedation for indications other than to tolerate ventilators (e.g., epilepsy);
* Continuous sedation is unlikely to be required during mechanical ventilation (e.g. Guillain-Barre syndrome);
* Patients determined by the clinician to be unlikely to be removed from mechanical ventilation, such as diseases/injuries that primarily affect respirator neuromuscular function and conditions that clearly require long-term ventilation support (such as high spinal cord injury);
* Participation in any other interventional study (any study that assigns subjects to different treatment gro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is currently suspended, can you find out why it was paused and whether there's any timeline for it to resume before we consider it as an option?
2This trial is specifically for patients needing sedation after oral and maxillofacial surgery — does my particular procedure and recovery situation actually match the type of patients this study is designed for?
3The main thing being measured in this trial is how quickly patients can be taken off the breathing machine after sedation — how does remimazolam besylate's expected effect on that compare to the sedation medications you would normally use for my procedure?
4Since this is a Phase 4 trial, meaning the drug has already been approved for some uses, what do we know so far about its safety profile in ICU patients on ventilators, and are there any risks specific to someone in my situation?
5Given that this trial is suspended right now, is there a standard sedation approach already available that we should be pursuing instead of waiting to see if this study reopens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Extubation time
Timeframe: From date of using the intervention drugs until the date of extubation, up to 28 days.
Trial details
NCT IDNCT05606315
SponsorNanfang Hospital, Southern Medical University