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

NCT01688648 | Completed

• 1 other identifier: 2012-07-098-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Coronary artery bypass graft; dexmedetomidine; lidocaine; myocardial injury; arrhythmia; blood electrolyte balance

Outcome Measures

Primary Outcomes (3)

• Myocardial injury marker

  Myocardial injury marker - CK-MB, and Troponin(i) blood level

  postoperative ICU day 1

• Myocardial injury marker

  Myocardial injury marker - CK-MB, and Troponin(i) blood level

  postoperative ICU day 2

• Myocardial injury marker

  Myocardial injury marker - CK-MB, and Troponin(i) blood level

  postoperative ICU day 3

Secondary Outcomes (5)

• 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

• The incidence of arrhythmia during and after the surgery

  1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3

• Postoperative ICU stay, Hospital stay, Extubation time

  1 day after hospital discharge

• Inotropics use during and after the surgery

  1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3

• 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

Study Arms (4)

Lidocaine group

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.

Drug: Lidocaine infusion

Dexmedetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine infusion

Combined infusion group

EXPERIMENTAL

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

Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion

Control group

NO INTERVENTION

The group without infusion of lidocaine or dexmedetomidine

Interventions

Lidocaine infusion DRUG

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.

Also known as: 2% lidocaine hydrochloride

Combined infusion group; Lidocaine group

Dexmedetomidine infusion DRUG

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

Also known as: Precedex injection, Dexmedetomidine hydrochloride 118 mcg/ml

Combined infusion group; Dexmedetomidine group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Angina, Unstable; Arrhythmias, Cardiac

Interventions

Lidocaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 20, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

KR (1)