Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively

ID
Name
21081102
Description
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.
Trial arms
Trial start
2021-10-28
Estimated PCD
2024-05-01
Trial end
2024-07-01
Status
Recruiting
Phase
Early phase I
Treatment
Dexamethasone 4mg
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Arms:
Group 1
Other names:
Group 1
Dexamethasone 8 Mg/mL Injectable Suspension
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Arms:
Group 2
Other names:
Group 2
Dexamethasone 16mg
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
Arms:
Group 3
Other names:
Group 3
Size
429
Primary endpoint
Opioid consumption
48-hours postoperative (after surgical intervention)
Eligibility criteria
Inclusion Criteria: * Age \> 18 years * Primary total knee arthroplasty * Patients staying at least one night in the hospital after surgery Exclusion Criteria: * Same day discharge Age \< 18 years Revision or partial total knee arthroplasty Corticosteroid use within 3 months prior to surgery Inflammatory arthritis Current systemic fungal infection Renal or liver failure Prior adverse reaction to corticosteroid Primary TKA requiring hardware removal
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 429, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

1 product

1 indication

Organization
Rush University Medical Center
Product
Dexamethasone
Indication
Knee Replacement