Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty

NCT ID: NCT01102491

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-03-31

Brief Summary

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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Ramosetron prophylaxis

ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery

Group Type: EXPERIMENTAL

Ramosetron

Intervention Type: DRUG

ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days

Control

no antiemetic prophylaxis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ramosetron

ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days

Intervention Type: DRUG

Other Intervention Names

Nasea

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

T K Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Joint Recontruction Center, Seoul National University Bundang hospital

Locations

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-1001/091-003

Identifier Type: -

Identifier Source: org_study_id