Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental | Sedation with remimazolam during spinal anesthesia |
|
| Dexmedetomidine group | Active Comparator | Sedation with dexmedetomidine during spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | After spinal anesthesia, 5 mg of remimazolam is injected by intravenous route for 1 minute to induce sedation. To maintain sedation, remimazolam is continuously infused at a rate within the range of 0.1 mg/kg/h to 1 mg/kg/h. |
| Measure | Description | Time Frame |
|---|---|---|
| MOAA/S score | MOAA/S score will be evaluated by an 5-point scale from iniation of sedative drugs to 30 minutes after PCAU arrival at 10 minutes intervals. | up to 30 minutes after PACU arrival |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation induction time Sedation induction time | Sedation induction time is defined as from start of drug injection to the first time of MOAA/S ≤ 3 | up to 5 minutes after initation of sedative drugs |
| Differences in basic vital signs between the two groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C522201 | remimazolam |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dexmedetomidine | Drug | After performing spinal anesthesia, dexmedetomidine is injected at a loading dose of 1 mcg/kg for 10 minutes to induce sedation. Thereafter, to maintain sedation, Dexmedetomidine is continuously infused at a rate within the range of 0.2 to 0.7 mcg/kg/h. |
|
Differences in blood pressure, heart rate, and patient sedation index at different time points during the operation and PACU stay between the two groups |
| Baseline |