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Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability.
A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results.
The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam 6 | Experimental | Remimazolam starts at 6 mg/kg/hr until loss of consciousness |
|
| Remimazolam 12 | Experimental | Remimazolam starts at 12 mg/kg/hr until loss of consciousness |
|
| Propofol | Active Comparator | Propofol starts at a target controlled infusion 4 µg/ml until loss of consciousness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Besylate 6 mg/kg/hr | Drug | Patients will receive remimazolam at 6 mg/kg/hr by continuous infusion until loss of consciousness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| difference in the decreased mean arterial pressure | difference between baseline mean arterial pressure and lowest mean arterial pressure | from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
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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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| Remimazolam Besylate 12 mg/kg/hr | Drug | Patients will receive remimazolam at 12 mg/kg/hr by continuous infusion until loss of consciousness. |
|
|
| Propofol | Drug | Patients will receive propofol at a target controlled infusion 4 µg/ml until loss of consciousness. |
|
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |