Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty
1 other identifier
interventional
291
1 country
1
Brief Summary
This study was conducted to determine the efficacy of an additional preemptive, single, low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting (PONV), pain level, and the safety in terms of wound complications in patients managed with our antiemetic protocol based on Ramosetron following TKA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 3, 2012
CompletedFirst Posted
Study publicly available on registry
June 6, 2012
CompletedResults Posted
Study results publicly available
May 21, 2013
CompletedMay 27, 2013
May 1, 2013
8 months
June 3, 2012
June 6, 2012
May 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Nausea and Vomiting
A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting
within 72 hours after surgery
Secondary Outcomes (2)
Pain Level
6 to 24 hours after surgery
Wound Complication
within 30 days after surgery
Study Arms (2)
Dexamethasone
EXPERIMENTALdexamethasone 10 mg administration 1 hour before surgery
Control
NO INTERVENTIONNo dexamethasone
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of primary osteoarthritis, knee
- Scheduled for elective total knee arthroplasty
- Signed written informed consent
You may not qualify if:
- Refusing participate
- Contraindication to regional anesthesia
- Severe impairment of bowel motility
- administration of other antiemetic drug within 24hours before surgery
- systemic steroid within 24hours before surgery
- history of cardiovascular \& respiratory disease
- renal \& hepatic failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tae Kyun Kimlead
Study Sites (1)
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. TK Kim
- Organization
- Joint Reconstruction Center, Seoul National University Bundang Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
T K Kim, MD, PhD
Joint Recontruction Center, Seoul National University Bundang hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Direcor, Joint reconstruction center, SNUBH
Study Record Dates
First Submitted
June 3, 2012
First Posted
June 6, 2012
Study Start
April 1, 2011
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
May 27, 2013
Results First Posted
May 21, 2013
Record last verified: 2013-05