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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | dexamethasone 10 mg administration 1 hour before surgery |
|
| Control | No Intervention | No dexamethasone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone 10 mg intravenous administration |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| T K Kim, MD, PhD | Joint Recontruction Center, Seoul National University Bundang hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Reconstruction Center, Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
14 patients were excluded before assignment. 5 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 4 had serious medical conditions such as renal failure, heary failure, 5 refused to participate
305 patients who were scheduled for unilateral total knee arthroplasty at Seoul National Bundang Hospital from April 2011 to December 2011 were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | dexamethasone 10 mg administration 1 hour before surgery |
| FG001 | Control | No dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | dexamethasone 10 mg administration 1 hour before surgery |
| BG001 | Control | No dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | 95% Confidence Interval | percentage of participant | within 72 hours after surgery |
|
30 days after total knee arthroplasty
wound complication such as postoperative infection, wound dehescence.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | dexamethasone 10 mg administration 1 hour before surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound complication | Surgical and medical procedures | Non-systematic Assessment | wound compltications within 30 days after total knee arthroplasty |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. TK Kim | Joint Reconstruction Center, Seoul National University Bundang Hospital | 82-31-787-7196 | 7200 | osktk@snubh.org |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D020250 | Postoperative Nausea and Vomiting |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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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 |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | 6 to 24 hours after surgery |
|
|
|
| Secondary | 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. | Posted | Number | participant | within 30 days after surgery |
|
|
|
| 1 |
| 146 |
| 0 |
| 146 |
| EG001 | Control | No dexamethasone | 1 | 145 | 0 | 145 |
|
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| D012216 |
| Rheumatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |