Dexamethasone 4mg
Drug4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Other names: Group 1
NCT Number: NCT05018091
The purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Stanford University, Redwood City, California, United States
Study design: Prospective randomized controlled trial
Scientific Background: In contemporary total joint arthroplasty (TJA), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 Multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. Corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols.
Corticosteroids are frequently used in TJA due to their potent anti-inflammatory and anti-emetic properties. Several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 However, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. In addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. Thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during TJA.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Other names: Group 1
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Other names: Group 2
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Other names: Group 3
Time frame: 48-hours postoperative (after surgical intervention)
48 hours of cumulative opioid consumption measured in oral morphine equivalents
Time frame: assessed at days 1 through 7 after surgery, Day 7 reported
Using 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
Time frame: assessed at days 1 through 7 after surgery, Day 7 reported
Using numeric rating scale, (0-10, where 10 is most nausea).
Time frame: Glucose levels taken the morning after surgery
check glucose levels in blood draws the morning after surgery in mg/dL
Time frame: Glucose levels taken the morning after surgery
check glucose levels, blood draws on morning after surgery measured in mg/dL
Time frame: Post op day 1, recording of hours slept
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Post op day 2, hours slept
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Post op day 3, hours slept
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Hours slept on POD 4
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Hours slept on POD 5
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Hours slept on POD 6
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: Hours slept on POD 7
recorded by patient, reported number of hours slept each night for first week after surgery
Time frame: <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery
Complications and Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization
Rush University Medical Center
Other
Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively
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