Effect of Remimazolam and Propofol on Postoperative Delirium

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Remimazolam and Propofol on Postoperative Delirium in Elderly Patients Undergoing Hip and Knee Surgery

Conditions
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Hip Fractures, Knee Osteoarthritis, Femur Fracture

Intervention / Treatment
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* Drug: Remimazolam (Byfavo)
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elderly patients undergoing hip or knee arthroplasty under general anesthesia. body mass index >30 kg/m2 Exclusion Criteria: moderate to severe liver dysfunction moderate to severe renal dysfunction unable to extubate in the operation room after operation benzodiazepine dependence sensitivity to anesthetic drugs used for study (Benzodiazepines, Propofol, Remifentanil, Fentanyl citrate, Rocuronium bromide, Sugammadex, Flumazenil) acute angle glaucoma received (benzodiazepine, antianxiety drugs, antidepressant, antipsychotic drugs) within 24 hours. acute psychotic depression history stroke or cerebrovascular disease

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam group<br>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. | Drug: Remimazolam (Byfavo)<br>* Remimazolam is continuously infused based on bispectral index (within 40-60).<br>|
| Active Comparator: Propofol group<br>Propofol is continuously infused within 1-5 μg/mL. | Drug: Propofol<br>* Propofol is continuously infused based on bispectral index (within 40-60).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |