Unstable AnginaNCT01688648
Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
A study testing Lidocaine infusion and Dexmedetomidine infusion in people with Unstable Angina and Coronary Artery Bypass Graft, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Unstable Angina, Coronary Artery Bypass Graft, Dexmedetomidine
- What is being tested?
- Lidocaine infusion and Dexmedetomidine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
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.
Read the detailed 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.
- Conditions
- Unstable Angina, Coronary Artery Bypass Graft, Dexmedetomidine, Lidocaine, Myocardial Injury, Arrhythmia
- Being tested
- Lidocaine infusion, Dexmedetomidine infusion
- Keywords
- Coronary artery bypass graft, dexmedetomidine, lidocaine, myocardial injury, arrhythmia, blood electrolyte balance
- Medical subject headings
- Angina, Unstable, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine infusionDrug
Also called 2% lidocaine hydrochloride
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 infusionDrug
Also called Precedex injection, Dexmedetomidine hydrochloride 118 mcg/ml
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Dexmedetomidine infusion |
| Combined infusion group | Experimental | Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group Receives: Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion |
| Control group | No intervention | The group without infusion of lidocaine or dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury marker
Myocardial injury marker - CK-MB, and Troponin(i) blood level
Measured: postoperative ICU day 1
Myocardial injury marker
Myocardial injury marker - CK-MB, and Troponin(i) blood level
Measured: postoperative ICU day 2
Myocardial injury marker
Myocardial injury marker - CK-MB, and Troponin(i) blood level
Measured: postoperative ICU day 3
Secondary outcomes (5)
The blood sodium, potassium, calcium level
The blood sodium, potassium, calcium level
Measured: 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
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
Measured: 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
Postoperative ICU stay, Hospital stay
Measured: 1 day after hospital discharge
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
Measured: 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
The incidence of hypokalemia
Measured: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable AnginaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Sung Cho, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688648
- Sponsor's protocol ID
- 2012-07-098-001
- Status last verified
- Oct 2014
- First submitted
- 10 Sep 2012
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT01688648
- Acronym / sponsor ID
- 2012-07-098-001
- Conditions
- Unstable Angina, Coronary Artery Bypass Graft, Dexmedetomidine, Lidocaine, Myocardial Injury, Arrhythmia
- Keywords
- Coronary artery bypass graft, dexmedetomidine, lidocaine, myocardial injury, arrhythmia, blood electrolyte balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: Lidocaine infusiona 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. |
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidine infusionDexmedetomidine 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 | Experimental | Drug: Lidocaine infusion, Drug: Dexmedetomidine infusionCombined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group |
| Control group | No intervention | –The group without infusion of lidocaine or dexmedetomidine |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine infusionAlso: 2% lidocaine hydrochloridea 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. | Drug | Combined infusion group, Lidocaine group |
| Dexmedetomidine infusionAlso: Precedex injection, Dexmedetomidine hydrochloride 118 mcg/mlDexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery | Drug | Combined infusion group, Dexmedetomidine group |
Primary outcome
Myocardial injury marker
Time frame: postoperative ICU day 1
Myocardial injury marker - CK-MB, and Troponin(i) blood level
Myocardial injury marker
Time frame: postoperative ICU day 2
Myocardial injury marker - CK-MB, and Troponin(i) blood level
Myocardial injury marker
Time frame: postoperative ICU day 3
Myocardial injury marker - CK-MB, and Troponin(i) blood level
5 secondary outcomes
The blood sodium, potassium, calcium level
Time frame: 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
Time frame: 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
Time frame: 1 day after hospital discharge
Inotropics use during and after the surgery
Time frame: 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
Time frame: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine infusion and Dexmedetomidine infusion in people with Unstable Angina and Coronary Artery Bypass Graft, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial injury marker (time frame: postoperative ICU day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.