Effect of Remimazolam and Propofol on Postoperative Delirium

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514405
• Other study ID #: 2022-03-002
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: March 2024
• Source: Inje University
• Contact: In-Jung Jun, MD PhD
• Phone: 82-10-9312-0162
• Email: christine17[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: August 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Femoral Fractures
• Femur Fracture
• Fractures, Bone
• Hip Fractures
• Knee Osteoarthritis

Intervention

Drug:
• Remimazolam (Byfavo)
Remimazolam is continuously infused based on bispectral index (within 40-60).
• Propofol
Propofol is continuously infused based on bispectral index (within 40-60).

Locations

Country	Name	City	State
Korea, Republic of	Sanggye Paik hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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