Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Ramosetron
Intervention type(s): Drug
Intervention description(s): ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days
Other intervention name(s): Nasea
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: postoperative nausea and vomiting