Remimazolam Besylate in Sedation of Postcardioperative Patients

NCT ID: NCT06716840

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2025-05-31

Brief Summary

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.

Conditions

Remimazolam; Propofol; Sedation; Mechanical Ventilation; Intensive Care; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Remimazolam group

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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.

propofol group

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First afflilated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Wenqiao PhD

Role: CONTACT

yuwenqiao1980@zju.edu.cn

+86-18868787588

Other Identifiers

2024-143

Identifier Type: -

Identifier Source: org_study_id