Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSoutheast University, China
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.
Eligibility criteria
Qualifiers
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;
Informed consent obtained from the patient's family
Disqualifiers
Body mass index (BMI) > 30 kg/m²
Severe central nervous system disease (e.g., acute stroke, uncontrolled seizures, or severe dementia) or any other condition that precludes RASS assessment
Mean arterial pressure (MAP) < 55 mmHg despite intravenous fluid resuscitation and vasopressors
Heart rate < 50 beats per minute, or second-degree or third-degree atrioventricular block in the absence of a pacemaker
Trial design
Treatments tested in this trial
- Remimazolam
- propofol
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov