Abstract
BackgroundRamosetron is a relatively new 5-hydroxytryptamine three receptor antagonist with higher binding affinity and more prolonged duration of action compared to ondansetron. The present study was performed to evaluate the effects of ramosetron on QTc interval and possible cardiovascular adverse effects in patients undergoing cardiac surgery.MethodA total of 114 patients who underwent off-pump coronary artery bypass surgery were enrolled in this randomised placebo-controlled trial. Patients were allocated into two groups that received intravenous injection of 0.3 mg ramosetron or normal saline during induction of anaesthesia. QTc intervals were measured before the operation, intraoperatively (0, 1, 2, 3, 5, 10, 15, 30, 45, 60, 90, 120, and 240 min after injection of ramosetron or normal saline), at the end of the operation, and on postoperative day 1.ResultsThere were no differences in mean QTc interval between groups at every time point. However, maximal change in QTc interval during surgery was higher in the ramosetron group than the placebo group (25.1 ± 22.0 vs. 17.5 ± 14.5 ms, 95 % CI 0.34–14.78, P = 0.040). Also, there were more patients with a QTc interval increase of > 60 ms in the ramosetron group (5 vs. 0, 95 % CI 1.6–18.0, P = 0.021). There were no significant differences in cardiovascular complications.ConclusionsRamosetron administered during induction of anaesthesia may affect maximal change in QTc interval during off-pump coronary artery bypass surgery. Ramosetron should be used with caution in high risk patients for developing Torsades de Pointes.Trial registrationClinicalTrials.gov NCT02139241. Registered November 12, 2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12871-016-0222-1) contains supplementary material, which is available to authorized users.
Highlights
Ramosetron is a relatively new 5-hydroxytryptamine three receptor antagonist with higher binding affinity and more prolonged duration of action compared to ondansetron
Maximal change in QTc interval during surgery was higher in the ramosetron group than the placebo group (25.1 ± 22.0 vs. 17.5 ± 14.5 ms, 95 % CI 0.34–14.78, P = 0.040)
Ramosetron administered during induction of anaesthesia may affect maximal change in QTc interval during off-pump coronary artery bypass surgery
Summary
Patients’ characteristics A total of 140 consecutive patients treated from June 2013 to October 2014 were enrolled in this study. Maximal change in QTc interval during surgery was higher in the ramosetron group than the placebo group (mean difference 7.56 ms, 95 % CI 0.34– 14.78, P = 0.040, Fig. 4). The number of patients with QTc interval increase > 60 ms was higher in the ramosetron group (risk difference 9.8 %, 95 % CI 1.6–18.0, P = 0.021) (Table 3). When applying the Hodges formula, maximal change in QTc interval was higher in the ramosetron group with a marginal significance (mean difference 8.81 ms, 95 % CI −0.99–18.61, P = 0.077). There were more patients with a QTc interval increase of > 60 ms in the ramosetron group (risk difference 9.8 %, 95 % CI 1.6–18.0, P = 0.021) (Additional file 1 shows QTc interval by Fridericia’s formula and Hodges formula). This study was not powered to assess the effect of ramosetron on postoperative complications
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