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The evidence on the practice of remimazolam besylate during cardiac anesthesia is scarce. This study investigates the efficacy and safety of remimazolam besylate general induction and maintenance during cardiac surgery.
Remimazolam besylate (RB), as a new benzodiazepine sedative agent, has been approved in clinical anesthesia with prominent characteristics of short onset/offset, less depression for cardiovascular or respiratory function and specific antagonist. Some studies have confirmed the comparable anesthesia efficacy of remimazolam for outpatient digestive endoscopy, fiberoptic bronchoscopy, facial plastic and orthopedic surgery as propofol. Currently, the evidence on its application in cardiac anesthesia is insufficient. Our study aims to evaluate the efficacy of remimazolam besylate and propofol and provide an ideal anesthetic agent to achieve the goal of early recovery after cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remimazolam besylate | Experimental | Patients received an initial dose of remimazolam (0.3mg/kg) for induction and a continuous infusion rate of 1 mg/kg/h for anesthesia maintenance. |
|
| propofol | Active Comparator | Patients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remimazolam besylate | Drug | Patients received an initial dose of remimazolam (0.3mg/kg) for induction and a continuous infusion rate of 1 mg/kg/h for anesthesia maintenance. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction. |
| Measure | Description | Time Frame |
|---|---|---|
| ratio of successful sedation during the whole surgery | Sedation success is defined as BIS locating in the range of 40-60 according to the required dosage without additional rescue sedative during the surgical procedures. | Intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| time interval for BIS from baseline before induction to 60 | Intraoperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| propofol | Drug | Patients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction. |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |