Femur Fracture, Hip Fractures, Knee Osteoarthritis
Conditions
Brief summary
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.
Interventions
Remimazolam is continuously infused based on bispectral index (within 40-60).
DRUGPropofol
Propofol is continuously infused based on bispectral index (within 40-60).
Sponsors
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delirium 3 days after the end of operation | Upto 3 days after surgery | delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of recovery (QoR-15) 3 days after the end of the operation | Upto 3 days after surgery | QoR-15 survey is performed preoperatively and 3 days after surgery. |
Countries
South Korea
Contacts
CONTACTIn-Jung Jun, MD PhD
STUDY_CHAIRIn-Jung Jun, MD PhD
Inje University
Outcome results
None listed