Effect of Remimazolam and Propofol on Postoperative Delirium

Inje University

Status: Enrolling

Conditions: Hip Fractures; Femur Fracture; Knee Osteoarthritis

Treatments: Drug: Remimazolam (Byfavo); Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05514405

2022-03-002

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

Remimazolam group

Experimental group

Description:

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.

Treatment:

Drug: Remimazolam (Byfavo)

Propofol group

Active Comparator group

Description:

Propofol is continuously infused within 1-5 μg/mL.

Treatment:

Drug: Propofol