Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients

NCT ID: NCT06496165

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2026-12-31

Brief Summary

In the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. For these patients, current guideline recommended propofol over benzodiazepine, mainly because of the short elimination half life of propofol. However, hypotension, a very common side effect of propofol, may impose restrictions on its use in some cardiac surgery patients. Remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite. In other words, remimazolam has both the property of quick offset of effect like propofol and the stable hemodynamic effect like midazolam, making it favorable for use as a sedative in cardiac surgery patients. The aim of this study is to evaluate the hemodynamic effect of remimazolam besylate versus propofol in patients undergoing cardiac surgery.

Conditions

Coronary Artery Disease

Study Design

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

Study Groups

remimazolam

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

Intravenous pump injection. The loading dose will be 0.1mg/kg, the maintenance dose will be 0.1-0.5mg/kg/h, with the target RASS be -2-0

propofol

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Intravenous pump injection. The loading dose will be 0.5mg/kg, the maintenance dose will be 1-4mg/kg/h, with the target RASS be -2-0

Interventions

Remimazolam

Intravenous pump injection. The loading dose will be 0.1mg/kg, the maintenance dose will be 0.1-0.5mg/kg/h, with the target RASS be -2-0

Intervention Type: DRUG

Propofol

Intravenous pump injection. The loading dose will be 0.5mg/kg, the maintenance dose will be 1-4mg/kg/h, with the target RASS be -2-0

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sign the informed consent form voluntarily and follow the plan requirements;
• age over 60 years old;
• post coronary artery bypass surgery;
• anticipated mechanical ventilation duration >8 hours
• admission to the cardiac surgery intensive care unit of Zhongshan hospital, Fudan University

Exclusion Criteria

• delirium before surgery
• severe cognitive dysfunction before surgery
• patients with over degree II A-V block or consistent bradycardia
• patients who are still not awake 12 hours after surgery
• patients who are agitated or cannot follow command
• patients with mechanical circulatory support (ECMO, IABP)
• patients who are allergy to propofol or remimazolam
• BMI≥30kg/m2
• patients with much drainage, the surgery ask for blood pressure control or reopen the chest

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhe Luo

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital Fudan university

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Guo-wei Tu

Role: CONTACT

tu.guowei@zs-hospital.sh.cn

13501996995

Guang-wei Hao

Role: CONTACT

hao.guangwei@zs-hospital.sh.cn

02164041990

Facility Contacts

Guo-wei Tu

Role: primary

tu.guowei@zs-hospital.sh.cn

02164041990

Guang-wei Hao

Role: backup

hao.guangwei@zs-hospital.sh.cn

02164041990

Other Identifiers

REMAP

Identifier Type: -

Identifier Source: org_study_id