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: Immediately after surgical intervention (TKA) for days 1 through 7 after surgery
Using daily Defense and Veterans Pain Rating scale to rate pain at rest and with activity
Time frame: Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale.
Using numeric rating scale, (1-10, where 10 is most nausea, causing vomiting followed by number of times participant vomited in 24-hour period).
Time frame: Immediately following surgical intervention until discharge from hospital (up to 30 days after surgery if still in hospital)
check glucose levels in daily blood draws when inpatient at hospital, insulin if applicable
Time frame: immediately following surgery (intervention), number of days spent in the hospital after surgery to discharge, up to 30 days after intervention
Days inpatient at hospital after surgery
Time frame: Immediately after surgical intervention (TKA) for days 1 through 7 after surgery, recording 24 hour sleep patterns
recorded by patient, daily sleep schedule
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
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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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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