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NCT02480088

Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism

Completed Phase 4 Last updated 27 October 2017
What this trial tests

Phase 4 trial testing Ramosetron in Postoperative Nausea and Vomiting in 300 participants. Completed in 11 March 2015.

Timeline
22 September 2014
Primary endpoint
11 March 2015
11 March 2015

Quick facts

Lead sponsorYonsei University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment300
Start date22 September 2014
Primary completion11 March 2015
Estimated completion11 March 2015
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Yonsei University

Who can join

Adults 20 to 85, any sex, with Postoperative Nausea and Vomiting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain control, however, its use inevitably increases the incidence of postoperative nausea and vomiting (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the prevention and treatment of PONV. It is not clear which one has superior antiemetic efficacy for the prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of 5HT3 antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This study evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients using IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic efficacy of the ramosetron and palonosetron. The incidence and intensity of PONV during postoperative 48 h will be assessed. ABCB1 polymorphisms 3435C\>T and 2677G\>T/A will be evaluated in all patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.
    Weibel S, Rücker G, Eberhart LH, Pace NL, et al · · 2020 · cited 125× · PMID 33075160 · DOI 10.1002/14651858.cd012859.pub2

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Other trials of Ramosetron

Trials testing the same drug.

Other recruiting trials for Postoperative Nausea and Vomiting

Currently open trials in the same condition.

Other Yonsei University trials

Trials by the same sponsor.

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