Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee |
Drug: Ramosetron |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Effect of Multimodal Anti-emetic Protocol on Postoperative Nausea and Vomiting After Total Knee Arthroplasty |
- Incidence of Nausea and Vomiting [ Time Frame: within 48 hours after surgery ] [ Designated as safety issue: No ]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
- Incidence of Rescue Antiemetic Administration [ Time Frame: within 48 hours after surgery ] [ Designated as safety issue: No ]outcome assessor assessed the incidence of rescue antiemetic administration
| Enrollment: | 153 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ramosetron prophylaxis
ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
|
Drug: Ramosetron
ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days
Other Name: Nasea
|
|
No Intervention: Control
no antiemetic prophylaxis
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 86 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 antiemetics within 24hours before surgery
- systemic steroid within 24hours before surgery
- history of cardiovascular & respiratory disease
- renal & hepatic failure
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01102491 History of Changes |
| Other Study ID Numbers: | B-1001/091-003 |
| Study First Received: | April 8, 2010 |
| Results First Received: | April 26, 2010 |
| Last Updated: | June 3, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul National University Hospital:
|
postoperative nausea and vomiting |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Postoperative Nausea and Vomiting Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Postoperative Complications Pathologic Processes Nausea Signs and Symptoms, Digestive Signs and Symptoms Vomiting Antiemetics |
Ramosetron Emetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013