Remimazolam Besylate in Sedation of Postcardioperative Patients

NCT06716840 | Recruiting

• 1 other identifier: 2024-143
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• extubation time

  up to 2 days

• extubation success rate

  up to 4 days

• changes in blood pressure

  up to 2 days

• changes in heart rate

  up to 2 days

• ventilator-free days

  From enrollment to 7 days

Study Arms (2)

Remimazolam group

EXPERIMENTAL

Drug: Remimazolam

propofol group

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Remimazolam 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.

Remimazolam group

Propofol 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.

propofol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

First afflilated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Yu Wenqiao PhD

CONTACT

+86-18868787588; yuwenqiao1980@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 4, 2024
• Study Start: February 10, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the study results are published
• 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

Locations

CN (1)