Effect of Remimazolam and Propofol on Postoperative Delirium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Hip Fractures Knee Osteoarthritis Femur Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Remimazolam (Byfavo)

Intervention Type DRUG

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

Propofol group

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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Remimazolam (Byfavo)

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes