Effect of Remimazolam and Propofol on Postoperative Delirium

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis; Hip Fractures; Femur Fracture
• Interventions: Drug: Remimazolam (Byfavo); Drug: Propofol

• Registration Number: NCT05514405
• Lead Sponsor: Inje University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam group	Remimazolam (Byfavo)	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.
Propofol group	Propofol	Propofol is continuously infused within 1-5 μg/mL.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Sanggye Paik hospital; 🇰🇷 Seoul, Korea, Republic of