Trial Outcomes & Findings for Dexamethasone in Total Knee Arthroplasty (NCT NCT05018091)
NCT ID: NCT05018091
Last Updated: 2026-08-03
Results Overview
48 hours of cumulative opioid consumption measured in oral morphine equivalents
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
438 participants
Primary outcome timeframe
48-hours postoperative (after surgical intervention)
Results posted on
2026-08-03
Participant Flow
Participant milestones
| Measure |
Dexamethasone 4mg
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Dexamethasone 8mg
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Dexamethasone 16mg
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Overall Study
STARTED
|
146
|
147
|
145
|
|
Overall Study
COMPLETED
|
138
|
137
|
129
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 8.8 • n=138 Participants
|
67.4 years
STANDARD_DEVIATION 9.1 • n=137 Participants
|
68.1 years
STANDARD_DEVIATION 8.9 • n=129 Participants
|
67.5 years
STANDARD_DEVIATION 8.9 • n=404 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=138 Participants
|
78 Participants
n=137 Participants
|
84 Participants
n=129 Participants
|
251 Participants
n=404 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=138 Participants
|
59 Participants
n=137 Participants
|
45 Participants
n=129 Participants
|
153 Participants
n=404 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 48-hours postoperative (after surgical intervention)48 hours of cumulative opioid consumption measured in oral morphine equivalents
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Opioid Consumption
|
72.8 mg morphine equivalents
Standard Deviation 47.8
|
101.0 mg morphine equivalents
Standard Deviation 168.9
|
93.8 mg morphine equivalents
Standard Deviation 122.3
|
SECONDARY outcome
Timeframe: assessed at days 1 through 7 after surgery, Day 7 reportedUsing daily Defense and Veterans Pain Rating scale (VPRS) to rate pain at rest, on a scale of 0-10 where 0 means no pain and 10 is the highest pain
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Postoperative Pain Scores at Rest
|
3.8 scores on a scale
Standard Deviation 2.0
|
3.7 scores on a scale
Standard Deviation 1.9
|
4.3 scores on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: assessed at days 1 through 7 after surgery, Day 7 reportedUsing numeric rating scale, (0-10, where 10 is most nausea).
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Postoperative Nausea
|
0.07 scores on a scale
Standard Deviation 0.3
|
0.46 scores on a scale
Standard Deviation 1.6
|
0.52 scores on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Glucose levels taken the morning after surgerycheck glucose levels in blood draws the morning after surgery in mg/dL
Outcome measures
| Measure |
Group 3
n=106 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=113 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=118 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Postoperative Blood Glucose Levels Without Diabetes
|
139.1 mg/dL
Standard Deviation 39.5
|
124.3 mg/dL
Standard Deviation 23.6
|
123.9 mg/dL
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: Glucose levels taken the morning after surgerycheck glucose levels, blood draws on morning after surgery measured in mg/dL
Outcome measures
| Measure |
Group 3
n=23 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=25 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=19 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Postoperative Blood Glucose Levels With Diabetes
|
178.1 mg/dL
Standard Deviation 48.1
|
157.8 mg/dL
Standard Deviation 40.5
|
148.8 mg/dL
Standard Deviation 49.8
|
SECONDARY outcome
Timeframe: Post op day 1, recording of hours sleptrecorded by patient, reported number of hours slept each night for first week after surgery
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Number of Hours Slept Post Op Day 1
|
5.6 hours slept
Standard Deviation 2.1
|
5.7 hours slept
Standard Deviation 2.5
|
5.4 hours slept
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Post op day 2, hours sleptrecorded by patient, reported number of hours slept each night for first week after surgery
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Number of Hours Slept Post Op Day 2
|
6.0 hours slept
Standard Deviation 1.9
|
6.5 hours slept
Standard Deviation 2.4
|
6.2 hours slept
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Post op day 3, hours sleptrecorded by patient, reported number of hours slept each night for first week after surgery
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Number of Hours Slept Post Op Day 3
|
6.6 hours slept
Standard Deviation 1.9
|
6.7 hours slept
Standard Deviation 2.0
|
6.6 hours slept
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Hours slept on POD 4recorded by patient, reported number of hours slept each night for first week after surgery
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Number of Hours Slept Post Op Day 4
|
6.6 hours slept
Standard Deviation 2.1
|
6.6 hours slept
Standard Deviation 2.2
|
6.6 hours slept
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Hours slept on POD 5recorded by patient, reported number of hours slept each night for first week after surgery
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Number of Hours Slept Post Op Day 5
|
6.5 hours slept
Standard Deviation 2.1
|
6.4 hours slept
Standard Deviation 2.0
|
6.6 hours slept
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Hours slept on POD 6recorded by patient, reported number of hours slept each night for first week after surgery
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Number of Hours Slept Post Op Day 6
|
6.2 hours slept
Standard Deviation 2.1
|
6.3 hours slept
Standard Deviation 2.0
|
6.3 hours slept
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Hours slept on POD 7recorded by patient, reported number of hours slept each night for first week after surgery
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Number of Hours Slept Post Op Day 7
|
6.2 hours slept
Standard Deviation 2.0
|
6.2 hours slept
Standard Deviation 1.9
|
6.4 hours slept
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgeryComplications and Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization
Outcome measures
| Measure |
Group 3
n=129 Participants
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 1
n=138 Participants
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 Participants
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Number of Participants With Complications up to 30 Days After Surgical Intervention
|
7 Participants
|
5 Participants
|
5 Participants
|
Adverse Events
Group 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=138 participants at risk
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 participants at risk
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 3
n=129 participants at risk
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Manipulation under anesthesia for stiffness after total knee replacement
|
1.4%
2/138 • Number of events 2 • Complications that occurred within 90-days after surgery were collected from all sites
|
0.73%
1/137 • Number of events 1 • Complications that occurred within 90-days after surgery were collected from all sites
|
2.3%
3/129 • Number of events 3 • Complications that occurred within 90-days after surgery were collected from all sites
|
Other adverse events
| Measure |
Group 1
n=138 participants at risk
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 4mg: 4mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 2
n=137 participants at risk
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 8 Mg/mL Injectable Suspension: 8mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
Group 3
n=129 participants at risk
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Dexamethasone 16mg: 16mg intravenous dexamethasone, administered shortly after induction of anesthesia
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Aseptic Wound Complication following total knee replacement
|
2.2%
3/138 • Number of events 3 • Complications that occurred within 90-days after surgery were collected from all sites
|
0.73%
1/137 • Number of events 1 • Complications that occurred within 90-days after surgery were collected from all sites
|
2.3%
3/129 • Number of events 3 • Complications that occurred within 90-days after surgery were collected from all sites
|
Additional Information
What is the Safest and Most Effective Dose of IV Dexamethasone in TKA? A Multicenter Randomized Cont
Rush University Medical Center
Phone: 3124322468
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place