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The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Active Comparator | A maintenance dose of remimazolam is administered for sedation |
|
| Propofol | Active Comparator | A maintenance dose of propofol is administered for sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Patients receive remimazolam at a rate of 1 mg/kg/hr. When a patient's MOAA/S reaches 3 or less, the rate of remomazolam is maintained at a rate between 0.3 mg/kr/hr and 1.0 mg/kg/hr until the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of hypotension during surgery (1hour) | mean blood pressure less than 65mmHg | up to 1 hour after initiation of drug infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of hypotension during surgery | mean blood pressure less than 65mmHg | Throughout the surgery |
| Total administered phenylephrine | total dose of phenylephrine administered during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion. |
|
| Throughout the surgery |
| Fluid volume | Total amount of fluid infused during surgery | Throughout the surgery |
| Number of hypotensive episodes in the post-anesthesia care unit after surgery | mean blood pressure less than 65mmHg | up to 1 hour after postanesthesia care unit entry |
| Complications after surgery | Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting | up to 7 days after surgery |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |