Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU
Recruiting
Phase 3
Interventional Study
Remimazolam Besylate
Mechanically Ventilated ICU Patients
Sedation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Southeast University, China · Other
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About This Trial
The goal of this clinical trial is to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients through a single-center, prospective, randomized controlled, pilot study.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years;
* Endotracheal intubation and mechanical ventilation for 24-96 hours before enrollment Expected need for continued invasive ventilation and sedation for at least 24 hours;
* Target sedation depth on the Richmond Agitation-Sedation Scale (RASS) between 0 and -3;…
Contacts