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The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery

The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02139241
Enrollment
114
Registered
2014-05-15
Start date
2013-06-30
Completion date
2014-10-31
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Graft Triple Vessel, Hypotension

Brief summary

The purpose of this study is to assess the effects of ramosetron on corrected QT interval in patients undergoing off pump coronary artery bypass surgery.

Interventions

DRUGRamosetron

0.3 mg IV as bolus before induction of general anesthesia

DRUGNormal saline

2 ml normal saline as bolus before induction of general anesthesia

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Elective off-pump coronary artery bypass graft surgery

Exclusion criteria

* Emergency operation * preoperative use of any inotropics or mechanical assist device * severe liver disease (\>Child class II) * dialysis dependent renal failure * Left ventricular ejection fraction \<30 % * Combined major surgery like carotid endarterectomy * Previous allergy history to any 5-hydroxytryptamine type 3 (5-HT3) antagonist * Preoperative QT prolongation ( 500 \>msec) or arrhythmia

Design outcomes

Primary

MeasureTime frameDescription
corrected QT interval (QTc interval)up to 240 minutes after induction of general anesthesiaat 1,2,3,5,10,15,30,45,60,90,120,240 minutes after ramosetron injection, at the time of operation end, ICU 12hour

Secondary

MeasureTime frame
hypotension or bradycardia during the peri-induction period and the coronary anastomosis periodup to 240 minutes after induction of general anesthesia
incidence of postoperative atrial fibrillationduring the hospital stay (from ICU admission to hospital discharge, average of 1 week)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026