Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>dexamethasone 10 mg administration 1 hour before surgery | Drug: Dexamethasone<br>* Dexamethasone 10 mg intravenous administration<br>|
| No Intervention: Control<br>No dexamethasone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Level | A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain). | 6 to 24 hours after surgery | 
| Wound Complication | Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured. | within 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative nausea and vomiting, postoperative pain