Effect of Remimazolam and Propofol on Postoperative Delirium

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Hip Fractures; Femur Fracture
• Intervention / Treatment: Drug: Remimazolam (Byfavo); Drug: Propofol

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: In-Jung Jun, MD PhD; Phone Number: 82-10-9312-0162; Email: christine17@hanmail.net

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Sanggye Paik hospital
    • Contact: In-Jung Jun; Phone Number: 82-10-9312-0162; Email: christine17@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of delirium 3 days after the end of operation	delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination	Upto 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of recovery (QoR-15) 3 days after the end of the operation	QoR-15 survey is performed preoperatively and 3 days after surgery.	Upto 3 days after surgery

Collaborators and Investigators

• Sponsor: Inje University
• Investigators: Study Chair: In-Jung Jun, MD PhD, Inje University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Arthritis; Joint Diseases; Rheumatic Diseases; Leg Injuries; Fractures, Bone; Osteoarthritis; Hip Injuries; Osteoarthritis, Knee; Femoral Fractures; Hip Fractures; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; remimazolam
• Other Study ID Numbers: 2022-03-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No