Remimazolam Besylate in Sedation of Postcardioperative Patients

Remimazolam Besylate Versus Propofolfor Sedation of Postcardioperative Patients in Intensive Care Unit: a Prospective,Single-center,Randomized Non-inferior Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Sedation; Intensive Care; Mechanical Ventilation; Propofol; Remimazolam
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Wenqiao PhD; Phone Number: +86-18868787588; Email: yuwenqiao1980@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • First afflilated hospital of zhejiang university school of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam group	Drug: Remimazolam; participants in the remimazolam group received remimazolam besylate intravenously at an initial infusion rate of 0.2mg/kg/h and adjusted (maximum of 2 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale(RASS) score between - 2 and 0.If the maximum dose of remimazolam was insufficient to sedate, add rescue dexmedetomidine.
Active Comparator: propofol group	Drug: Propofol; participants in the propofol group received propofol intravenously at an initial infusion rate of 1 mg/kg/h and adjusted (maximum of 4 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale (RASS) score between - 2 and 0.If the maximum dose of propofol was insufficient to sedate, add rescue dexmedetomidine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of time in the target sedation range	The primary outcome was the percentage of time in the target sedation range without rescue sedation.	up to 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extubation time	from stopping sedative medication to removing the endotracheal tube	up to 2 days
extubation success rate	no re-intubation within 48 hours after extubation	up to 4 days
changes in blood pressure	dynamic changes of blood pressure were recorded during sedation	up to 2 days
changes in heart rate	dynamic changes of heart rate were recorded during sedation	up to 2 days
ventilator-free days	ventilator-free days at day 7	From enrollment to 7 days
the score of confusion assessment method for the intensive care unit ( CAM-ICU)	diagnose the delirium by the CAM-ICU score，and calculate the incidence of delirium	From enrollment to the end of treatment at 28 days
stay length	length of intensive care unit stay and hospital stay	From enrollment to the end of treatment at 28 days
28-day mortality	28-day mortality after enrollment	From enrollment to the end of treatment at 28 days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: 2024-143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After the study results are published
• IPD Sharing Access Criteria: You can explain the reason and contact the study initiator via email to request the data. The email address is:yuwenqiao1980@zju.edu.cn
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No