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Completed

NCT Number: NCT02139241

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

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.

Completed

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Key information

Conditions

Coronary Artery Bypass Graft Triple Vessel Cardiovascular Diseases Hypotension Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramosetron

Drug

0.3 mg IV as bolus before induction of general anesthesia

Other names: Nasea

normal saline

Drug

2 ml normal saline as bolus before induction of general anesthesia

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 15, 2014
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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