Comparing Remimazolam and Propofol for Delirium After Surgery
Effect of Remimazolam and Propofol on Postoperative Delirium in Elderly Patients Undergoing Hip and Knee Surgery
NA · Inje University · NCT05514405
This study is testing whether remimazolam or propofol is better at preventing confusion after surgery in older patients getting hip or knee replacements.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 65 Years to 100 Years |
| Sex | All |
| Sponsor | Inje University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05514405 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effects of remimazolam and propofol on the incidence of postoperative delirium in elderly patients undergoing orthopedic surgeries such as hip or knee arthroplasty. Remimazolam is an ultra-short acting benzodiazepine that is rapidly metabolized, potentially offering advantages over propofol, particularly in geriatric anesthesia. The study will assess recovery profiles and the occurrence of delirium in patients receiving either anesthetic. By evaluating these two agents, the research seeks to identify the safer option for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients with a body mass index greater than 30 who are scheduled for hip or knee arthroplasty under general anesthesia.
Not a fit: Patients with moderate to severe liver or renal dysfunction, or those with a history of benzodiazepine dependence or acute psychotic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced delirium rates in elderly patients undergoing orthopedic surgery.
How similar studies have performed: While the use of remimazolam has been explored in various contexts, this specific comparison with propofol regarding postoperative delirium is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Sanggye Paik hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: In-Jung Jun, MD PhD
- Email: christine17@hanmail.net
- Phone: 82-10-9312-0162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hip Fractures, Knee Osteoarthritis, Femur Fracture