Effect of Remimazolam and Propofol on Postoperative Delirium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam (Byfavo), Propofol.
- Who it may be relevant to
- Registry conditions: Hip Fractures, Knee Osteoarthritis, Femur Fracture. Basic parameters: 65 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Remimazolam and Propofol on Postoperative Delirium in Elderly Patients Undergoing Hip and Knee Surgery
Overview
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.
Interventions
- Drug Remimazolam (Byfavo)
Remimazolam is continuously infused based on bispectral index (within 40-60). - Drug Propofol
Propofol is continuously infused based on bispectral index (within 40-60).
Primary outcome measures
- Incidence of delirium 3 days after the end of operation [Time frame: Upto 3 days after surgery]
Secondary outcome measures (1)
- quality of recovery (QoR-15) 3 days after the end of the operation [Time frame: Upto 3 days after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
South Korea · 1 center
- Sanggye Paik hospital — Seoul
Identifiers
NCT: NCT05514405 · 2022-03-002