NCT05514405

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Aug 2022Sep 2026

Study Start

First participant enrolled

August 1, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

August 23, 2022

Last Update Submit

March 24, 2026

Conditions

Hip FracturesKnee OsteoarthritisFemur Fracture

Outcome Measures

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

    Upto 3 days after surgery

Secondary Outcomes (1)

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

    Upto 3 days after surgery

Study Arms (2)

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.

Drug: Remimazolam (Byfavo)

Propofol group

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

PropofolDRUG

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

Propofol group
Remimazolam (Byfavo)DRUG

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

Remimazolam group

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanggye Paik hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hip FracturesOsteoarthritis, KneeFemoral Fractures

Interventions

remimazolamPropofol

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • In-Jung Jun, MD PhD

    Inje University

    STUDY CHAIR

Central Study Contacts

In-Jung Jun, MD PhD

CONTACT

82-10-9312-0162christine17@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 24, 2022

Study Start

August 1, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

KR(1)