About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
elderly patients undergoing hip or knee arthroplasty under general anesthesia.
body mass index >30 kg/m2
Disqualifiers
moderate to severe liver dysfunction
moderate to severe renal dysfunction
unable to extubate in the operation room after operation
benzodiazepine dependence
Trial design
Parallel
Treatments tested in this trial
Remimazolam (Byfavo)
DrugRemimazolam is continuously infused based on bispectral index (within 40-60).
Propofol
DrugPropofol is continuously infused based on bispectral index (within 40-60).
Treatment groups
Trial outcomes
Primary outcomes
Incidence of delirium 3 days after the end of operation
delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination
Secondary outcomes
quality of recovery (QoR-15) 3 days after the end of the operation
QoR-15 survey is performed preoperatively and 3 days after surgery.
Sponsors and contacts
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