MedDataX Logo

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

NCT ID: NCT02139241

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Bypass Graft Triple Vessel Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ramosetron

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

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

0.3 mg IV as bolus before induction of general anesthesia

Control

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

2 ml normal saline as bolus before induction of general anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ramosetron

0.3 mg IV as bolus before induction of general anesthesia

Intervention Type DRUG

Normal saline

2 ml normal saline as bolus before induction of general anesthesia

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nasea

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19261954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22100822 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27488394 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ramosetron_opcab

Identifier Type: -

Identifier Source: org_study_id