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

Primary Purpose

Coronary Artery Bypass Graft Triple Vessel, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron
Normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Bypass Graft Triple Vessel

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ramosetron

Control

Arm Description

Intravenous administration of ramosetron 0.3 mg before the induction of general anesthesia

Intravenous administration of 2ml normal saline before the induction of general anesthesia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

hypotension or bradycardia during the peri-induction period and the coronary anastomosis period
incidence of postoperative atrial fibrillation

Full Information

First Posted
November 12, 2013
Last Updated
November 17, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02139241
Brief Title
The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery
Official Title
The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Graft Triple Vessel, Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ramosetron
Arm Type
Experimental
Arm Description
Intravenous administration of ramosetron 0.3 mg before the induction of general anesthesia
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Intravenous administration of 2ml normal saline before the induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Other Intervention Name(s)
Nasea
Intervention Description
0.3 mg IV as bolus before induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
2 ml normal saline as bolus before induction of general anesthesia
Primary Outcome Measure Information:
Title
corrected QT interval (QTc interval)
Description
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 Outcome Measure Information:
Title
hypotension or bradycardia during the peri-induction period and the coronary anastomosis period
Time Frame
up to 240 minutes after induction of general anesthesia
Title
incidence of postoperative atrial fibrillation
Time Frame
during the hospital stay (from ICU admission to hospital discharge, average of 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19261954
Citation
Havrilla PL, Kane-Gill SL, Verrico MM, Seybert AL, Reis SE. Coronary vasospasm and atrial fibrillation associated with ondansetron therapy. Ann Pharmacother. 2009 Mar;43(3):532-6. doi: 10.1345/aph.1L544. Epub 2009 Mar 3.
Results Reference
background
PubMed Identifier
22100822
Citation
Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.
Results Reference
background
PubMed Identifier
27488394
Citation
Kim TK, Cho YJ, Lim CW, Min JJ, Choi EK, Hong DM, Jeon Y. Effect of ramosetron on QTc interval: a randomised controlled trial in patients undergoing off-pump coronary artery bypass surgery. BMC Anesthesiol. 2016 Aug 3;16(1):56. doi: 10.1186/s12871-016-0222-1.
Results Reference
derived

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

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