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
| Name | Class |
|---|---|
| Hana Pharm Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Bolus injection and continuous infusion are two widely used methods for intravenous administration of drugs. Bolus injection possibly leads to a rather high drug plasma concentration temporarily, however, it can induce a rapid onset of drug effects and attain a desired clinical state fast. On the contrary, continuous infusion is able to avoid excessive drug levels in plasma, but it takes longer to achieve the proper effect.
In this study, the investigators hypothesize that the bolus injection of remimazolam can reduce anesthesia induction time when compared to the continuous infusion of remimazolam, and also maintain hemodynamic stability. (The researchers will investigate the effect of the bolus injection of remimazolam during anesthesia induction in terms of its safety and efficacy when compared with the continuous infusion.)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus group | Experimental | Participants in this group are administered remimazolam via the bolus injection method during anesthesia induction. |
|
| Infusion group | Active Comparator | Participants in this group are administered remimazolam via the continuous infusion method during anesthesia induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bolus injection of remimazolam | Drug | Participants in this group are administered 0.2 mg/kg remimazolam via the bolus injection method for 20 seconds during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will administer additional doses of 0.05 mg/kg repeatedly until LOC occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| MOAA/SS (sedation level) | The investigators will measure MOAA/SS from the start of remimazolam administration to loss of consciousness (LOC), and compare it between the two groups. | From initiation of remimazolam to LOC (up to 5 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from initiation of drug administration to bispectral index(BIS) <60 | The investigators measure how long it takes from the start of remimazolam administration to reach BIS <60. | From initiation of remimazolam to BIS <60 (up to 10 minutes) |
| BIS |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Byung Gun Lim, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Infusion of remimazolam | Drug | Participants in this group are administered remimazolam at a rate of 6 mg/kg/hr via the continuous infusion method during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will escalate infusion dose to 12 mg/kg/hr until LOC occurs. |
|
|
The investigators will measure BIS from the start of remimazolam administration to 15 minutes after surgical incision.
| From initiation of remimazolam to 15 minutes after surgical incision |
| Hemodynamic stability (i.e. blood pressure, heart rate) | The investigators will evaluate hemodynamic stability from the start of remimazolam administration to 15 minutes after surgical incision | From initiation of remimazolam to 15 minutes after surgical incision |