NCT05514405 Effect of Remimazolam and Propofol on Postoperative Delirium
| NCT ID | NCT05514405 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inje University |
| Condition | Hip Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2022-08-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
In-Jung Jun, MD PhD
STUDY CHAIR
Inje University
Frequently Asked Questions
Who can join the NCT05514405 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 100 Years, studying Hip Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05514405 currently recruiting?
Yes, NCT05514405 is actively recruiting participants. Contact the research team at christine17@hanmail.net for enrollment information.
Where is the NCT05514405 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05514405 clinical trial?
NCT05514405 is sponsored by Inje University. The principal investigator is In-Jung Jun, MD PhD at Inje University. The trial plans to enroll 82 participants.