Postoperative Nausea and Vomiting Clinical Trial
Postoperative pain, the great concern for the patients undergoing spine surgery, has led to
common use of opioid-based intravenous patient-controlled analgesia (IV-PCA)
postoperatively. Opioid-based IV-PCA offers better pain control, which could facilitate
early recovery, rehabilitation and increase patient satisfaction. However, its use
inevitably increases the incidence of postoperative nausea and vomiting (PONV), another
great discomfort, as high as 80% in patients with multiple risk factors.Therefore, there
have been consistent efforts to prevent PONV with multimodal therapies such as risk
stratification, modification and preventive use of antiemetics.
Of all antiemetics, 5-hydroxytryptamine (5-HT3) antagonist, especially ondansetron, is most
commonly used and extensively studied to reduce PONV because of its efficacy and fewer side
effects.[8] However, its efficacy is not quite satisfactory when it comes to PONV associated
with opioid-based IV-PCA. Recently, there are many reports comparing the antiemetic efficacy
between ondansetron and the 2 newly developed 5-HT3 antagonists, ramosetron and
palonosetron. Ramosetron is known to have a higher affinity and longer duration of binding
to 5-HT3 receptor, therefore exhibits potent and sustained anti-emetic effect than
previously developed 5-HT3 antagonists.Palonosetron has a unique allosteric binding to the
5-HT3 receptor, which brings a higher affinity, longer duration of action and longer
elimination half-time.According to the previous studies, both ramosetron and palonosetron
showed superior antiemetic efficacy for PONV associated with opioid-based IV-PCA to
ondansetron as expected by their theoretical advantages. However, it has never been
evaluated which one has superior antiemetic efficacy for opioid-based IV-PCA associated
PONV. Therefore, in this study, we tried to evaluate the relative antiemetic efficacy of
ramosetron and palonosetron in controlling opioid-based IV-PCA related PONV.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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