ClinicalTrials.gg
RecruitingNCT05514405Updated Mar 27, 2026

Effect of Remimazolam and Propofol on Postoperative Delirium

An interventional study of Remimazolam (Byfavo) and Propofol in Hip Fractures, Knee Osteoarthritis and Femur Fracture, sponsored by Inje University. Recruiting at 1 site in South Korea. Open to participants aged 65 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Inje University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
65 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hip Fractures
  • Knee Osteoarthritis
  • Femur Fracture
03

In context

Hip Fractures

842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.

This study's planned enrollment of 82 is close to the median of 86 across 533 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

Inje University is the lead sponsor of 93 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • elderly patients undergoing hip or knee arthroplasty under general anesthesia.
  • >30 kg/m2

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
82 participants (estimated)

Study arms

  • Experimental
    Remimazolam group

    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.

    Drug: Remimazolam (Byfavo)

  • Active comparator
    Propofol group

    Propofol is continuously infused within 1-5 μg/mL.

    Drug: Propofol

Interventions

  • Remimazolam is continuously infused based on bispectral index (within 40-60).

  • Propofol is continuously infused based on bispectral index (within 40-60).

06

What researchers measure

Primary outcomes

  1. Incidence of delirium 3 days after the end of operation

    delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination

    Time frame: 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.

    Time frame: Upto 3 days after surgery

07

Study locations

1 of 1 sites recruiting
  • Sanggye Paik hospital
    Seoul, South Korea
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2022 (actual). Primary completion is estimated for Aug 2026, 48 months after the start.

Of 221 non-industry interventional studies with no phase under Hip Fractures, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 55. This study's planned 48 months is above that.

Counting every sponsor, half of 237 studies reached it within 29 months; a quarter within 10 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2022
First posted
Aug 24, 2022
StartActual
Aug 1, 2022
Primary completionEst.
Aug 31, 2026
CompletionEst.
Sep 30, 2026
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05514405
Lead sponsor
Inje University
Responsible party
In-Jung Jun (assisstant professor, Inje University) — Principal investigator
First posted
Aug 24, 2022
Start date
Aug 1, 2022
Primary completion
Aug 31, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Mar 27, 2026

Study contacts

In-Jung Jun, MD PhD
Contact
christine17@hanmail.net
82-10-9312-0162
In-Jung Jun, MD PhD
study chair · Inje University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Remimazolam besilate

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