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

Not Applicable

Completed

• Conditions: Coronary Artery Bypass Graft Triple Vessel; Hypotension
• Interventions: Drug: Ramosetron; Drug: Normal saline

• Registration Number: NCT02139241
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-11-12
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Elective off-pump coronary artery bypass graft surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ramosetron	Ramosetron	Intravenous administration of ramosetron 0.3 mg before the induction of general anesthesia
Control	Normal saline	Intravenous administration of 2ml normal saline before the induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
corrected QT interval (QTc interval)	up to 240 minutes after induction of general anesthesia	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

Secondary Outcome Measures

Name	Time	Method
hypotension or bradycardia during the peri-induction period and the coronary anastomosis period	up to 240 minutes after induction of general anesthesia
incidence of postoperative atrial fibrillation	during the hospital stay (from ICU admission to hospital discharge, average of 1 week)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of