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Remimazolam is an ultra-short acting benzodiazepine agonist which is used widely for general anesthesia and sedation. Remimazolam has several advantages. Remimazolam is rapidly metabolized by tissue esterase that it does not accumulate even after infusion for long periods of time. The presence of reversal agents (flumazenil) is also advantageous. Also, hemodynamic stability compared to propofol gives clinicians preference to use for geriatric anesthesia. However, the study on the effect of remimazolam compared to propofol on postoperative delirium have not been carried out. The purpose of the study is to compare the incidence of postoperative delirium and recovery profile in elderly patients undergoing orthopedic surgery using either remimazolam or propofol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental | Remimazolam is started during induction of anesthesia at the rate of 6 mg/kg/hr and continued at the rate of 1 mg/kg/hr (within 0.3-2 mg/kg/hr). Remimazolam is stopped 20 minutes before end of operation. |
|
| Propofol group | Active Comparator | Propofol is continuously infused within 1-5 μg/mL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam (Byfavo) | Drug | Remimazolam is continuously infused based on bispectral index (within 40-60). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium 3 days after the end of operation | delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination | Upto 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| quality of recovery (QoR-15) 3 days after the end of the operation | QoR-15 survey is performed preoperatively and 3 days after surgery. | Upto 3 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| In-Jung Jun, MD PhD | Contact | 82-10-9312-0162 | christine17@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| In-Jung Jun, MD PhD | Inje University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanggye Paik hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D020370 | Osteoarthritis, Knee |
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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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 | Propofol is continuously infused based on bispectral index (within 40-60). |
|
| D010003 |
| Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |