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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102491
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : May 21, 2010
Last Update Posted : June 8, 2012
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Ramosetron Phase 4

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  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Multimodal Anti-emetic Protocol on Postoperative Nausea and Vomiting After Total Knee Arthroplasty
Study Start Date : September 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Nasea
No Intervention: Control
no antiemetic prophylaxis

Primary Outcome Measures :
  1. Incidence of Nausea and Vomiting [ Time Frame: within 48 hours after surgery ]
    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

Secondary Outcome Measures :
  1. Incidence of Rescue Antiemetic Administration [ Time Frame: within 48 hours after surgery ]
    outcome assessor assessed the incidence of rescue antiemetic administration

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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01102491

Korea, Republic of
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: T K Kim, MD,PhD Joint Recontruction Center, Seoul National University Bundang hospital

Responsible Party: Seoul National University Hospital Identifier: NCT01102491     History of Changes
Other Study ID Numbers: B-1001/091-003
First Posted: April 13, 2010    Key Record Dates
Results First Posted: May 21, 2010
Last Update Posted: June 8, 2012
Last Verified: June 2012

Keywords provided by Seoul National University Hospital:
postoperative nausea and vomiting

Additional relevant MeSH terms:
Osteoarthritis, Knee
Postoperative Nausea and Vomiting
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action