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

Seoul National University Hospital114 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

114

Conditions

Coronary Artery Bypass Graft Triple Vessel Hypotension

Interventions

RamosetronDRUG

0.3 mg IV as bolus before induction of general anesthesia

Normal salineDRUG

2 ml normal saline as bolus before induction of general anesthesia

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

corrected QT interval (QTc interval)

at 1,2,3,5,10,15,30,45,60,90,120,240 minutes after ramosetron injection, at the time of operation end, ICU 12hour

Time frame: up to 240 minutes after induction of general anesthesia

Secondary Outcomes

hypotension or bradycardia during the peri-induction period and the coronary anastomosis period

Time frame: up to 240 minutes after induction of general anesthesia

incidence of postoperative atrial fibrillation

Time frame: during the hospital stay (from ICU admission to hospital discharge, average of 1 week)

Data from ClinicalTrials.gov

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