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Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery

NCT01825733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2014-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

ramosetron

Ramosetron 0.3 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.

DRUG

palonosetron

palonosetrno 0.075 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-07-31
Completion
2012-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825733 on ClinicalTrials.gov