Effect of Remimazolam and Propofol on Postoperative Delirium in Elderly Patients Undergoing Hip and Knee Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Remimazolam (Byfavo)
- Conditions
- Hip Fractures
- Sponsor
- Inje University
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Incidence of delirium 3 days after the end of operation
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
In-Jung Jun
assisstant professor
Inje University
Eligibility Criteria
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
Arms & Interventions
Remimazolam group
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.
Intervention: Remimazolam (Byfavo)
Propofol group
Propofol is continuously infused within 1-5 μg/mL.
Intervention: Propofol
Outcomes
Primary Outcomes
Incidence of delirium 3 days after the end of operation
Time Frame: Upto 3 days after surgery
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(Upto 3 days after surgery)