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Effect of Remimazolam and Propofol on Postoperative Delirium

Primary Purpose

Hip Fractures, Knee Osteoarthritis, Femur Fracture

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Remimazolam (Byfavo)

Propofol

About this trial

This is an interventional other trial for Hip Fractures

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Sanggye Paik hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam group

Propofol group

Arm Description

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 is continuously infused within 1-5 μg/mL.

Outcomes

Primary Outcome Measures

Incidence of delirium 3 days after the end of operation

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT05514405

First Posted

August 23, 2022

Last Updated

October 4, 2023

Sponsor

Inje University

1. Study Identification

Unique Protocol Identification Number

NCT05514405

Brief Title

Effect of Remimazolam and Propofol on Postoperative Delirium

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Inje University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Fractures, Knee Osteoarthritis, Femur Fracture

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Remimazolam group

Arm Type

Experimental

Arm Description

Arm Title

Propofol group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Remimazolam (Byfavo)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of delirium 3 days after the end of operation

Description

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

Time Frame

Upto 3 days after surgery

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Upto 3 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

In-Jung Jun, MD PhD

Phone

82-10-9312-0162

christine17@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In-Jung Jun, MD PhD

Organizational Affiliation

Inje University

Official's Role

Study Chair

Facility Information:

Facility Name

Sanggye Paik hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

In-Jung Jun

Phone

82-10-9312-0162

christine17@hanmail.net

12. IPD Sharing Statement

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Effect of Remimazolam and Propofol on Postoperative Delirium

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