Image

Remimazolam Besylate in Sedation of Postcardioperative Patients

Remimazolam Besylate in Sedation of Postcardioperative Patients

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation,in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finally,the investigators will compare the sedation effect and safety between the 2 groups ,to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.

Eligibility

Inclusion Criteria:

  1. age ≥ 18 years ;
  2. admitted to the intensive care unit after cardiac surgery with techanical ventilation;
  3. expected to extubation within 48hours ;
  4. participant has given informed consent

Exclusion Criteria:

  1. pregnant or lactating women
  2. known or suspected hypersensitivity to the study drug
  3. history of impaired consciousness or psychiatric illness
  4. severe bradycardia with a heart rate of < 50 beats per minute
  5. systolic blood pressure < 90 mmHg with fluid resuscitation and vasopressor maintenance
  6. atrioventricular block(II or III degree), Left ventricular ejection fraction(LVEF) <30%
  7. participated in other clinical studies within 3 months

Study details
    Remimazolam
    Propofol
    Sedation
    Mechanical Ventilation
    Intensive Care
    Cardiac Surgery

NCT06716840

First Affiliated Hospital of Zhejiang University

14 October 2025

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.