Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
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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.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis, Knee |
Drug: Dexamethasone |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty |
- Incidence of nausea and vomiting [ Time Frame: within 72 hours after surgery ] [ Designated as safety issue: No ]
- Pain level [ Time Frame: within 72 hours after surgery ] [ Designated as safety issue: No ]
- wound complication [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]wound infection within 30 days after total knee arthroplasty
Enrollment: | 291 |
Study Start Date: | April 2011 |
Study Completion Date: | January 2012 |
Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Dexamethasone
dexamethasone 10 mg administration 1 hour before surgery
|
Drug: Dexamethasone
Dexamethasone 10 mg intravenous administration
|
No Intervention: Control
No dexamethasone
|
Detailed Description:
Postoperative pain and emesis can cause postoperative systemic complications and delay recovery and rehabilitation in patients following total knee arthroplasty (TKA). Furthermore, patients who suffered from severe postoperative pain and emesis tend to be dissatisfied with their surgical treatments. Although contemporary protocols to control perioperative pain and emesis after TKA have been reported to substantially reduce postoperative pain and emesis compared with traditional measures, pain and emesis after TKA remain to be a challenging issue for patients and health care providers. In our previous study, the use of Ramosetron was found to reduce postoperative emetic events, but the antiemetic effects by Ramosetron were incomplete. In search of a further antiemetic measure, we identified the use of dexamethasone as the additional measure fortifying our antiemetic protocol using Ramosetron.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of primary osteoarthritis, knee
- Scheduled for elective total knee arthroplasty
- Signed written informed consent
Exclusion Criteria:
- 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
Korea, Republic of | |
Joint Reconstruction Center, Seoul National University Bundang Hospital | |
Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707 |
Principal Investigator: | T K Kim, MD, PhD | Joint Recontruction Center, Seoul National University Bundang hospital |
No publications provided
Responsible Party: | Tae Kyun Kim, Direcor, Joint reconstruction center, SNUBH, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01612702 History of Changes |
Other Study ID Numbers: | B-1102/121-006 |
Study First Received: | June 3, 2012 |
Last Updated: | June 5, 2012 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Seoul National University Hospital:
postoperative nausea and vomiting postoperative pain |
Additional relevant MeSH terms:
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012