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

NCT ID: NCT01688648

Last Updated: 2014-10-27

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-02-28

Brief Summary

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

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.

Detailed Description

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

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.

Conditions

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

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

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

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

Lidocaine group

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 Type EXPERIMENTAL

Lidocaine infusion

Intervention Type 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.

Dexmedetomidine group

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

Group Type EXPERIMENTAL

Dexmedetomidine infusion

Intervention Type DRUG

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

Combined infusion group

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

Group Type EXPERIMENTAL

Lidocaine infusion

Intervention Type 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.

Dexmedetomidine infusion

Intervention Type DRUG

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

Control group

The group without infusion of lidocaine or dexmedetomidine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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

2% lidocaine hydrochloride Precedex injection Dexmedetomidine hydrochloride 118 mcg/ml

Eligibility Criteria

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

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
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.

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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

Hyun Sung Cho

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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

South Korea

Other Identifiers

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

2012-07-098-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Protection During Cardiac Surgery.
NCT03230136 COMPLETED NA
Etomidate Versus Propofol in CABG Surgery
NCT06068764 RECRUITING PHASE4