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NCT Number: NCT05514405

Effect of Remimazolam and Propofol on Postoperative Delirium

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.

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Key information

Conditions

Hip Fractures Arthritis Femoral Fractures Femur Fracture Fractures, Bone Hip Injuries Joint Diseases Knee Osteoarthritis Leg Injuries Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Wounds and Injuries

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam (Byfavo)

Drug

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

Propofol

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. quality of recovery (QoR-15) 3 days after the end of the operation

    Time frame: Upto 3 days after surgery

    QoR-15 survey is performed preoperatively and 3 days after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

In-Jung Jun, MD PhD

CONTACT

[email protected]

82-10-9312-0162

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Effect of Remimazolam and Propofol on Postoperative Delirium in Elderly Patients Undergoing Hip and Knee Surgery

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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