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

NCT06496165 | Not Yet Recruiting DMC

• 1 other identifier: REMAP
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery

  Within 8 hours of study drug used

Secondary Outcomes (1)

• RASS score during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery

  Within 8 hours of study drug used

Other Outcomes (1)

• rate of delirium during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery

  Within 8 hours of study drug used

Study Arms (2)

remimazolam

EXPERIMENTAL

Drug: Remimazolam

propofol

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Remimazolam 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

remimazolam

Propofol 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

propofol

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan university

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Zhe Luo

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo-wei Tu

CONTACT

13501996995; tu.guowei@zs-hospital.sh.cn

Guang-wei Hao

CONTACT

02164041990; hao.guangwei@zs-hospital.sh.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: July 3, 2024
• First Posted: July 11, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

CN (1)