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NCT Number: NCT06496165

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: Within 8 hours of study drug used

Study contacts

Contact information is provided by the study sponsor or research team.

Guang-wei Hao

CONTACT

[email protected]

02164041990

Guo-wei Tu

CONTACT

[email protected]

13501996995

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Comparison of the Effects of Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients：a Prospective, Single Blinded, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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