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

November 17, 2015 updated by: Seoul National University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ramosetron
Intravenous administration of ramosetron 0.3 mg before the induction of general anesthesia
Drug: Ramosetron
0.3 mg IV as bolus before induction of general anesthesia
Other Names:
  • Nasea
Placebo Comparator: Control
Intravenous administration of 2ml normal saline before the induction of general anesthesia
Drug: Normal saline
2 ml normal saline as bolus before induction of general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corrected QT interval (QTc interval)
Time Frame: 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
up to 240 minutes after induction of general anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
hypotension or bradycardia during the peri-induction period and the coronary anastomosis period
Time Frame: up to 240 minutes after induction of general anesthesia
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)
during the hospital stay (from ICU admission to hospital discharge, average of 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ramosetron_opcab

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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