Completed

The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft

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What is being tested

Lidocaine infusion

+ Dexmedetomidine infusion

+ Lidocaine infusion

Drug
Who is being recruted

Angina Pectoris+10

+ Cardiovascular Diseases

+ Chest Pain

From 20 to 80 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorSamsung Medical Center
Last updated: October 27, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

Lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. A previous study has reported that low-dose lidocaine infusion can decrease the incidence of ventricular fibrillation and tachycardia during the first 24 hours after coronary artery bypass graft (CABG). A recent study also reported that the lidocaine infusion during CABG could decrease the myocardial injury by measuring the CK-MB and Troponin-I blood level. Dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine stress response. Dexmedetomidine was reported to have a cardioprotective effect by a previous animal study. However, there was no clinical study evaluating the cardioprotective effect of dexmedetomidine. Therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

NCT01688648
Principal SponsorSamsung Medical Center
Last updated: October 27, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Angina PectorisCardiovascular DiseasesChest PainHeart DiseasesNeurologic ManifestationsPainPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaAngina, UnstableArrhythmias, Cardiac

Criteria

1 inclusion criteria required to participate
Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center
4 exclusion criteria prevent from participating
Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
Patients with recent exogenous steroid administration or previous diuretics therapy
Patients with recent myocardial infarction
Those undergoing unplanned cardiopulmonary bypass during the surgery

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
a bolus dose of lidocaine 1.5 mg/kg after anesthetic induction with following lidocaine infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.

Group II

Experimental
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery

Group III

Experimental
Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group

Group IV

No Intervention
The group without infusion of lidocaine or dexmedetomidine

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Samsung Medical Center

Seoul, South KoreaOpen Samsung Medical Center in Google Maps
CompletedOne Study Center