Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam, Propofol.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Drug 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 - 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
Primary outcome measures
- 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 outcome measures (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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital Fudan university — Shanghai
Identifiers
NCT: NCT06496165 · REMAP