Image

Long-term Sedation With Remimazolam Besylate in Critically Ill Patients

Long-term Sedation With Remimazolam Besylate in Critically Ill Patients

Recruiting
18-80 years
All
Phase 3

Powered by AI

Overview

A randomized non-inferior trial comparing remimazolam besylate with propofol for long-term sedation during invasive mechanical ventilation in critically ill patients

Eligibility

Inclusion Criteria:

  • Age ≥ 18 and ≤ 80 years;
  • Intubated and mechanically ventilated ≤96 hours before enrollment;
  • Expected to require continuous invasive ventilation and sedation ≥24 hours;
  • Requirement for light to moderate sedation (a RASS score of -3 to 0)

Exclusion Criteria:

  • Body mass index (BMI) <18 or >30 kg/m2;
  • Allergy or unsuitabilty to any composition of study drugs or remifentanil;
  • Living expectancy less than 48 hours;
  • Possible surgey in the operating room in 24 hours;
  • Myasthenia gravis;
  • Serious hepatic dysfunction (CTP 10-15);
  • Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2;
  • Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
  • Acute severe neurological disorder and any other condition interfering with RASS assessment;
  • Pregnancy or lactation;
  • Unstable angina or acute myocardial infarction;
  • Left ventricular ejection fraction less than 30%;
  • Heart rate less than 50 beats/min;
  • Grade 2 , second degree or third degree atrioventricular block in the absence of a pacemaker;
  • Abuse of controlled substances or alcohol;
  • Other conditions deemed unsuitable to be included;

Study details
    Light Sedation
    Mechanical Ventilation

NCT05555667

Wuhan Union Hospital, China

25 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.