How Many Dexamethasone Doses Should Be Given Perioperatively?

NCT06715709 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 24-008239
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the most efficient and safest dexamethasone dose given perioperatively during total knee arthroplasty that reduces postoperative option consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications

Conditions

Arthropathy of Knee

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Cumulative opioid consumption within 72 hours after Total Knee Arthroplasty, measured in oral morphine milligram equivalents.

  72 hours

Secondary Outcomes (1)

• Sleeplesssness

  7 days

Study Arms (3)

(1) dexamethasone administered intraoperatively at the time of anesthesia

OTHER

(1) dexamethasone administered intraoperatively at the time of anesthesia

Drug: Dexamethasone IV

(2) dexamethasone administered intraoperatively and on the morning of the first postoperative day,

EXPERIMENTAL

(2) dexamethasone administered intraoperatively and on the morning of the first postoperative day,

Drug: Dexamethasone IV+Oral

(3) dexamethasone administered intraoperatively, the morning of the first& second postoperative day

EXPERIMENTAL

(3) dexamethasone administered intraoperatively, the morning of the first postoperative day, and the morning of the second postoperative day.

Drug: Dexamethasone IV+Oral 2 Day

Interventions

Dexamethasone IV DRUG

Patients will receive dexamethasone administered intraoperatively at the time of anesthesia. The dose of dexamethasone will be 16mg intravenous (IV) if you do not have a prior diagnosis of diabetes mellitus, or 8mg IV if you do have a previous diagnosis of diabetes mellitus.

(1) dexamethasone administered intraoperatively at the time of anesthesia

Dexamethasone IV+Oral DRUG

Patients will receive dexamethasone administered intraoperatively and on the morning of the first postoperative day. The dose of dexamethasone will be 16mg intravenous (IV) if you do not have a prior diagnosis of diabetes mellitus, or 8mg IV if you do have a previous diagnosis of diabetes mellitus. The medication will be intravenously administered while inpatient, and via oral route when discharged.

(2) dexamethasone administered intraoperatively and on the morning of the first postoperative day,

Dexamethasone IV+Oral 2 Day DRUG

Patients will receive dexamethasone administered intraoperatively, the morning of the first postoperative day, and the morning of the second postoperative day. The dose of dexamethasone will be 16mg intravenous (IV) if you do not have a prior diagnosis of diabetes mellitus, or 8mg IV if you do have a previous diagnosis of diabetes mellitus. The medication will be intravenously administered while inpatient, and via oral route when discharged.

(3) dexamethasone administered intraoperatively, the morning of the first& second postoperative day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Primary total knee arthroplasty

You may not qualify if:

• Age \< 18 year
• Revision or unicompartmental knee arthroplasty
• Corticosteroid use within 3 months prior to TKA
• Inflammatory arthritis
• Current systemic fungal infection
• Renal or liver failure
• Prior adverse reaction to corticosteroid
• Primary TKA requiring hardware removal

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Charles Hannon

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: March 25, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)