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It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (0.02 mg/kg, age<65) | Active Comparator | Remimazolam of 0.02 mg/kg will be infused in patients aged<65. |
|
| 2 (0.07 mg/kg, age<65) | Active Comparator | Remimazolam of 0.07 mg/kg will be infused in patients aged<65. |
|
| 3 (0.12 mg/kg, age<65) | Active Comparator | Remimazolam of 0.12 mg/kg will be infused in patients aged<65. |
|
| 4 (0.17 mg/kg, age<65) | Active Comparator | Remimazolam of 0.17 mg/kg will be infused in patients aged<65. |
|
| 5(0.22 mg/kg, age<65) | Active Comparator | Remimazolam of 0.22 mg/kg will be infused in patients aged<65. |
|
| 6(0.27 mg/kg, age<65) | Active Comparator | Remimazolam of 0.27 mg/kg will be infused in patients aged<65. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.02 mg/kg, age<65 | Drug | Remimazolam of 0.02 mg/kg will be infused in patients aged<65. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Loss of consciousness within 5 minutes | Loss of consciousness will be evaluated at 5 minutes after infusion. | At 5 minutes after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Time to loss of consciousness | Time to loss of consciousness will be assessed at 5 minutes after infusion. | At 5 minutes after infusion (time to loss of consciousness) |
| blood pressure | Blood pressure will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong Woo Han | GangnamSeveracne Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35562226 | Derived | Chae D, Kim HC, Song Y, Choi YS, Han DW. Pharmacodynamic analysis of intravenous bolus remimazolam for loss of consciousness in patients undergoing general anaesthesia: a randomised, prospective, double-blind study. Br J Anaesth. 2022 Jul;129(1):49-57. doi: 10.1016/j.bja.2022.02.040. Epub 2022 May 11. |
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|
| 7 (0.02 mg/kg, age≥65) | Active Comparator | Remimazolam of 0.02 mg/kg will be infused in patients aged≥65. |
|
| 8 (0.07 mg/kg, age≥65) | Active Comparator | Remimazolam of 0.07 mg/kg will be infused in patients aged≥65. |
|
| 9 (0.12 mg/kg, age≥65) | Active Comparator | Remimazolam of 0.12 mg/kg will be infused in patients aged≥65. |
|
| 10 (0.17 mg/kg, age≥65) | Active Comparator | Remimazolam of 0.17 mg/kg will be infused in patients aged≥65. |
|
| 11 (0.22 mg/kg, age≥65) | Active Comparator | Remimazolam of 0.22 mg/kg will be infused in patients aged≥65. |
|
| 12 (0.27 mg/kg, age≥65) | Active Comparator | Remimazolam of 0.27 mg/kg will be infused in patients aged≥65. |
|
| 0.07 mg/kg, age<65 | Drug | Remimazolam of 0.07 mg/kg will be infused in patients aged<65. |
|
| 0.12 mg/kg, age<65 | Drug | Remimazolam of 0.12 mg/kg will be infused in patients aged<65. |
|
| 0.17 mg/kg, age<65 | Drug | Remimazolam of 0.17 mg/kg will be infused in patients aged<65. |
|
| 0.22 mg/kg, age<65 | Drug | Remimazolam of 0.22 mg/kg will be infused in patients aged<65. |
|
| 0.27 mg/kg, age<65 | Drug | Remimazolam of 0.27 mg/kg will be infused in patients aged<65. |
|
| 0.02 mg/kg, age≥65 | Drug | Remimazolam of 0.02 mg/kg will be infused in patients aged≥65. |
|
| 0.07 mg/kg, age≥65 | Drug | Remimazolam of 0.07 mg/kg will be infused in patients aged≥65. |
|
| 0.12 mg/kg, age≥65 | Drug | Remimazolam of 0.12 mg/kg will be infused in patients aged≥65 |
|
| 0.17 mg/kg, age≥65 | Drug | Remimazolam of 0.17 mg/kg will be infused in patients aged≥65. |
|
| 0.22 mg/kg, age≥65 | Drug | Remimazolam of 0.22 mg/kg will be infused in patients aged≥65. |
|
| 0.27 mg/kg, age≥65 | Drug | Remimazolam of 0.27 mg/kg will be infused in patients aged≥65. |
|
| At 5 minutes after infusion |
| heart rate | Heart rate will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion. | At 5 minutes after infusion |
| sedline | Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion. | At 5 minutes after infusion |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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