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New treatment option for Remimazolam Besylate
Official title Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU
ClinicalTrials.gov ID: NCT07596589
What this study is testing
What is Remimazolam?
Remimazolam is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for remimazolam besylate.
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
- 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.
- Phase 3: a large, late-stage study
- 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 and older
You may be able to join if
- Age ≥ 18 years;
- Endotracheal intubation and mechanical ventilation for 24-96 hours before enrollment Expected need for continued invasive ventilation and sedation...
- Target sedation depth on the Richmond Agitation-Sedation Scale (RASS) between 0 and -3;
- Informed consent obtained from the patient's family
You likely can't join if
- 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...
- 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
- Acute myocardial infarction or severe heart failure (New York Heart Association [NYHA] class IV)
- Left ventricular ejection fraction \< 30%
See the full eligibility 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;
- Informed consent obtained from the patient's family
- 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
- Acute myocardial infarction or severe heart failure (New York Heart Association [NYHA] class IV)
- Left ventricular ejection fraction \< 30%
- Any contraindication or allergy to benzodiazepines
- Substance dependence, alcohol abuse, or psychiatric/psychological disorders. Alcohol abuse was defined as regular consumption of \> 14 drinks per week (1 drink = 150 mL wine, 360 mL beer, or 45 mL liquor)
- Acute hepatitis or severe hepatic dysfunction (Child-Pugh class C)
- Chronic kidney disease with a glomerular filtration rate (GFR) \< 60 mL/min/1.73 m²
- Neuromuscular disease
- Patients on extracorporeal membrane oxygenation (ECMO)
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, 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.