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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remimazolam | Experimental |
| |
| propofol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery | Within 8 hours of study drug used |
| Measure | Description | Time Frame |
|---|---|---|
| RASS score during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery | Within 8 hours of study drug used |
| Measure | Description | Time Frame |
|---|---|---|
| rate of delirium during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery | Within 8 hours of study drug used |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo-wei Tu | Contact | 13501996995 | tu.guowei@zs-hospital.sh.cn | |
| Guang-wei Hao | Contact | 02164041990 | hao.guangwei@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhe Luo | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan university | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 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 |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |