Effect of Remimazolam and Propofol on Postoperative Delirium

Sponsor

Inje University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05514405

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures Knee Osteoarthritis Femur Fracture	Drug: Remimazolam (Byfavo) Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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.

Drug: Remimazolam (Byfavo)

Remimazolam is continuously infused based on bispectral index (within 40-60).

Active Comparator: Propofol group

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

Drug: Propofol

Propofol is continuously infused based on bispectral index (within 40-60).

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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