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

The Effect of Multimodal Anti-emetic Protocol on Postoperative Nausea and Vomiting After Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Ramosetron

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Joint Reconstruction Center, Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Nasea
No Intervention: Control; no antiemetic prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Rescue Antiemetic Administration	outcome assessor assessed the incidence of rescue antiemetic administration	within 48 hours after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: T K Kim, MD,PhD, Joint Recontruction Center, Seoul National University Bundang hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 9, 2010
• First Posted (Estimate): April 13, 2010

Study Record Updates

• Last Update Posted (Estimate): June 8, 2012
• Last Update Submitted That Met QC Criteria: June 3, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: postoperative nausea and vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Vomiting; Nausea; Osteoarthritis, Knee; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Ramosetron
• Other Study ID Numbers: B-1001/091-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No