Hip FracturesNCT05514405
Effect of Remimazolam and Propofol on Postoperative Delirium
A study testing Remimazolam (Byfavo) and Propofol in people with Hip Fractures and Knee Osteoarthritis, run by Inje University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Knee Osteoarthritis, Femur Fracture
- What is being tested?
- Remimazolam (Byfavo) and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- elderly patients undergoing hip or knee arthroplasty under general anesthesia.
- body mass index >30 kg/m2
Who cannot join
- 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
Show all 9Show fewer
- received (benzodiazepine, antianxiety drugs, antidepressant, antipsychotic drugs) within 24 hours.
- acute psychotic depression
- history stroke or cerebrovascular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Sanggye Paik hospital
Seoul
In-Jung Jun, 82-10-9312-0162, christine17@hanmail.net
About this study
Official title: Effect of Remimazolam and Propofol on Postoperative Delirium in Elderly Patients Undergoing Hip and Knee Surgery
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.
- Conditions
- Hip Fractures, Knee Osteoarthritis, Femur Fracture
- Being tested
- Remimazolam (Byfavo), Propofol
- Medical subject headings
- Hip Fractures, Osteoarthritis, Knee, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam (Byfavo)Drug
Remimazolam is continuously infused based on bispectral index (within 40-60).
PropofolDrug
Propofol is continuously infused based on bispectral index (within 40-60).
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | 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. Receives: Drug: Remimazolam (Byfavo) |
| Propofol group | Active comparator | Propofol is continuously infused within 1-5 μg/mL. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium 3 days after the end of operation
delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination
Measured: Upto 3 days after surgery
Secondary outcomes (1)
quality of recovery (QoR-15) 3 days after the end of the operation
QoR-15 survey is performed preoperatively and 3 days after surgery.
Measured: Upto 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Jung Jun, Inje University
- Investigators
- In-Jung Jun, MD PhD, Study chair, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514405
- Sponsor's protocol ID
- 2022-03-002
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam and Propofol on Postoperative Delirium in Elderly Patients Undergoing Hip and Knee Surgery
- ClinicalTrials.gov ID
- NCT05514405
- Acronym / sponsor ID
- 2022-03-002
- Conditions
- Hip Fractures, Knee Osteoarthritis, Femur Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: 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 | Active comparator | Drug: PropofolPropofol is continuously infused within 1-5 μg/mL. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- elderly patients undergoing hip or knee arthroplasty under general anesthesia.
- body mass index >30 kg/m2
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam (Byfavo)Remimazolam is continuously infused based on bispectral index (within 40-60). | Drug | Remimazolam group |
| PropofolPropofol is continuously infused based on bispectral index (within 40-60). | Drug | Propofol group |
Primary outcome
Incidence of delirium 3 days after the end of operation
Time frame: Upto 3 days after surgery
delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination
1 secondary outcome
quality of recovery (QoR-15) 3 days after the end of the operation
Time frame: Upto 3 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
In-Jung Jun, MD PhD study chair
Inje University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam (Byfavo) and Propofol in people with Hip Fractures and Knee Osteoarthritis, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact In-Jung Jun, MD PhD (82-10-9312-0162, christine17@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium 3 days after the end of operation (time frame: Upto 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.