Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688648
• Other study ID #: 2012-07-098-001
• Status: Completed
• Phase: N/A
• First received: September 10, 2012
• Last updated: October 24, 2014
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center

Exclusion Criteria:

• 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Angina, Unstable
• Arrhythmia
• Blood Electrolyte Balance
• Coronary Artery Bypass Graft
• Dexmedetomidine
• Lidocaine
• Myocardial Injury
• Unstable Angina

Intervention

Drug:
• Lidocaine infusion
a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
• Dexmedetomidine infusion
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial injury marker	Myocardial injury marker - CK-MB, and Troponin(i) blood level	postoperative ICU day 1	No
Primary	Myocardial injury marker	Myocardial injury marker - CK-MB, and Troponin(i) blood level	postoperative ICU day 2	No
Primary	Myocardial injury marker	Myocardial injury marker - CK-MB, and Troponin(i) blood level	postoperative ICU day 3	No
Secondary	The blood sodium, potassium, calcium level	The blood sodium, potassium, calcium level	1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3	No
Secondary	The incidence of arrhythmia during and after the surgery	The incidence of arrhythmia during and after the surgery: Ventricular premature beat,Atrial premature complex, Bigeminy, Trigeminy, Atrial fibrillation, Ventricular tachycardia, Ventricular fibrillation, Atrio-Ventricular block, PSVT, Junctional rhythm, External pacing	1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3	Yes
Secondary	Postoperative ICU stay, Hospital stay, Extubation time	Postoperative ICU stay, Hospital stay	1 day after hospital discharge	No
Secondary	Inotropics use during and after the surgery	Inotropics and other drug use during and after the surgery: Dopamine, NTG, dobutamine, milrinone, epinephrine, norepinephrine, amiodarone, diltiazem, remifentanil, esmolol, labetalol, nicardipine, Lasix, phenylephrine, lidocaine, sufentanil	1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3	No
Secondary	The incidence of hypokalemia	The incidence of hypokalemia	1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3	No