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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139241
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Graft Triple Vessel Hypotension Drug: Ramosetron Drug: Normal saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery
Study Start Date : June 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. hypotension or bradycardia during the peri-induction period and the coronary anastomosis period [ Time Frame: up to 240 minutes after induction of general anesthesia ]
  2. incidence of postoperative atrial fibrillation [ Time Frame: during the hospital stay (from ICU admission to hospital discharge, average of 1 week) ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139241


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02139241    
Other Study ID Numbers: Ramosetron_opcab
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: May 2014
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action