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NCT03232125

Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position

Completed NA Last updated 25 August 2020
What this trial tests

NA trial testing Ramosetron in Prostate Cancer in 54 participants. Completed in 12 June 2020.

Timeline
1 August 2017
Primary endpoint
9 June 2020
12 June 2020

Quick facts

Lead sponsorYonsei University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment54
Start date1 August 2017
Primary completion9 June 2020
Estimated completion12 June 2020
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Yonsei University

Who can join

Adults 20 to 80, any sex, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads to changes in ventricular re-polarization. This in turn can result in changes of heart rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg position.

Publications & conference data

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

  1. Heart-Rate-Corrected QT Interval Response to Ramosetron during Robot-Assisted Laparoscopic Prostatectomy: A Randomized Trial.
    Lee B, Kim SY, Kim SH, Yang H, et al · · 2022 · PMID 35629233 · DOI 10.3390/jpm12050811

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Other trials of Ramosetron

Trials testing the same drug.

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other Yonsei University trials

Trials by the same sponsor.

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Data sources for this page

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