NCT02139241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 20, 2015

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

November 12, 2013

Last Update Submit

November 17, 2015

Conditions

Coronary Artery Bypass Graft Triple VesselHypotension

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 240 minutes after induction of general anesthesia

Secondary Outcomes (2)

  • 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)

Study Arms (2)

Ramosetron

EXPERIMENTAL

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

Drug: Ramosetron

Control

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

RamosetronDRUG

0.3 mg IV as bolus before induction of general anesthesia

Also known as: Nasea
Ramosetron
Normal salineDRUG

2 ml normal saline as bolus before induction of general anesthesia

Control

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective off-pump coronary artery bypass graft surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 19261954BACKGROUND

  • 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.

    PMID: 22100822BACKGROUND

  • 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.

    PMID: 27488394DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

ramosetronSaline Solution

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2013

First Posted

May 15, 2014

Study Start

June 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 20, 2015

Record last verified: 2014-05

Locations

KR(1)