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The purposes of this study are to document the antiemetic efficacy of multimodal antiemetic protocol in patient after Total Knee Arthroplasty using regional anesthesia, midazolam & propofol, hydration & oxygen supplement, preemptive & multimodal contemporary pain management and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect on this protocol. We hypothesized that the incidence of Postoperative nausea and vomiting during multimodal antiemetic protocol would be lower than Apfel's expected postoperative nausea and vomiting incidence. It was also hypothesized that Ramosetron prophylaxis would provide additional antiemetic effect.
Immediate postoperative pain after Total Knee Arthroplasty(TKA) remains an unsolved problem, and a substantial proportion of patients experience moderate to severe postoperative pain. Patient controlled analgesia(PCA) using opioid is an effective and safe modality for postoperative pain relief after TKA and remains an integral part of pain management after TKA. However, Opioid is associated with high incidence of postoperative nausea and vomiting(PONV) which is the most frequent complication during the first 24 hour after surgery.PONV has been reported to be more distressing than postoperative pain and to be the most undesirable negative outcome. Despite advances in prevention and treatment of PONV, PONV remains a continuing problem with an incidence of 20-30% in unselected patients and up to 70% in "high-risk" patients. As results of current researches, some risk factors of PONV have been identified and indications of prophylactic antiemetics and strategies to reduce baseline risk have been recommended.The recommended modalities to reduce baseline risk includes regional anesthesia, oxygen supplement, use of midazolam and propofol and avoid use of inhaled anesthesia and neuromuscular blockade. In addition,published evidence suggests that appropriate antiemetic prophylaxis should be considered for patients with 2 or more risk factors and to reduce opioid consumption, preemptive multimodal pain management such as preemptive analgesic medication, continuous regional nerve block is recommended.Ramosetron is a newly developed serotonin receptor antagonist with a higher affinity and longer duration of action than that of the previously developed serotonin receptor antagonist such as ondansetron and granisetron. Thus, this prospective blinded randomized study was conducted to document the antiemetic efficacy of multimodal antiemetic protocol to reduce baseline risk, using regional anesthesia, midazolam and propofol, hydration and oxygen supplement and multimodal pain control protocols using the continuous femoral nerve block, PCA and preemptive oral medications and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect in patients after TKA for whom covered by this multimodal antiemetic protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramosetron prophylaxis | Experimental | ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery |
|
| Control | No Intervention | no antiemetic prophylaxis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramosetron | Drug | ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nausea and Vomiting | outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting | within 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Rescue Antiemetic Administration | outcome assessor assessed the incidence of rescue antiemetic administration | within 48 hours after surgery |
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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 |
11 patients were excluded before assignment. 6 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 2 were refused to participate this study, and 3 were serious medical conditions such as respiratory failure, heart failure.
153 patients whose diagnosis was primary osteoarthritis scheduled for unilateral total knee arthroplasty(TKA)at Seoul National University Bundang Hospital from October 2009 to March 2010 were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramosetron Prophylaxis | ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery |
| FG001 | Control | no antiemetic prophylaxis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramosetron Prophylaxis | ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery |
| BG001 | Control | no antiemetic prophylaxis |
| 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 | outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting | Posted | Number | participants | within 48 hours after surgery |
|
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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 | Ramosetron Prophylaxis | ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| TK Kim | Joint Reconstruction Center, Seoul National University Bundang Hospital | 82-31-787-7196 | osktk@snubh.org |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C071315 | ramosetron |
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| 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 | Incidence of Rescue Antiemetic Administration | outcome assessor assessed the incidence of rescue antiemetic administration | Not Posted | within 48 hours after surgery |
| 27 |
| 71 |
| 4 |
| 71 |
| EG001 | Control | no antiemetic prophylaxis | 25 | 71 | 2 | 71 |
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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 |