Coronary Artery Bypass GraftNCT01572454
Comparison of Dexmedetomidine and Remifentanil Infusion During CABG
A study testing Dexmedetomidine infusion and Remifentanil infusion in people with Coronary Artery Bypass Graft and Hypokalemia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients undergoing off-pump coronary artery bypass graft, and trying compare these effects with those of remifentanil infusion. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Coronary Artery Bypass Graft, Hypokalemia, Cardiac Arrhythmia
- What is being tested?
- Dexmedetomidine infusion and Remifentanil infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Dec 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those undergoing off-pump coronary artery bypass graft during March, 2012 ~ February, 2013 in Samsung Medical Center
- Age between 20 and 70 yrs old
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Serum Potassium Concentration, Antiarrhythmic Effect, and Myocardial Protective Effect Between Dexmedetomidine and Remifentanil Infusion in Patients Undergoing Coronary Artery Bypass Surgery
We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients undergoing off-pump coronary artery bypass graft, and trying compare these effects with those of remifentanil infusion.
Read the detailed description
Alpha2-adrenergic agonist, dexmedetomidine, is recently used for sedation, analgesia or adjuvant to general anesthesia. Postsynaptic activation of alpha2 adrenoceptors in the central nervous system (CNS) inhibits sympathetic activity and thus can decrease blood pressure and heart rate. The blockade of sympathetic activity decrease the neuroendocrine stress response and may decrease the incidence of hypokalemia. The hypokalemia can increase the incidence of arrythmia, especially in cardiac patients. We postulated that dexmedetomidine could decrease the neuroendocrine stress response, thus decrease arrhythmia during cardiac surgery. Furthermore, dexmedetomidine have been reported to have cardioprotective effect with previous animal studies.
Therefore, the aim of the present study is to investigate whether the intraoperative dexmedetomidine infusion can reduce the incidence of hypokalemia and arrythmia, and myocardial injury in subjects undergoing off-pump coronary artery bypass graft. We are also trying to compare these effects with those of remifentanil infusion.
- Conditions
- Coronary Artery Bypass Graft, Hypokalemia, Cardiac Arrhythmia, Dexmedetomidine, Remifentanil
- Being tested
- Dexmedetomidine infusion, Remifentanil infusion
- Keywords
- coronary artery bypass graft, hypokalemia, cardiac arrhythmia, dexmedetomidine, remifentanil
- Medical subject headings
- Hypokalemia, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine infusionDrug
Also called Dexmedetomidine
Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
Remifentanil infusionDrug
Also called Remifentanil
Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery Receives: Drug: Dexmedetomidine infusion |
| Remifentanil group | Active comparator | Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery Receives: Drug: Remifentanil infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum potassium concentration
serum potassium concentration at the day before anesthetic induction
Measured: at 24 hour before anesthetic induction
serum potassium concentration
1 minutes before anesthetic induction (etomidate injection)
Measured: 1 minutes before anesthetic induction
serum potassium concentration
serum potassium concentration 20 minutes after start of anesthetic induction (at the end of anesthetic induction)
Measured: 20 minutes after start of anesthetic induction
serum potassium concentration
serum potassium concentration at 2 hour after anesthetic induction (after mammary artery dissection and graft formation)
Measured: 2 hour after the start of anesthetic induction
serum potassium concentration
serum potassium concentration at 3 hour after end of anesthetic induction (after the anastomosis of coronary graft)
Measured: 3 hour after start of anesthetic induction
Secondary outcomes (6)
arterial blood gas analysis results
arterial blood gas analysis results
Measured: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
incidence of hypokalemia
incidence of hypokalemia (serum K < 3.5) incidence of hypokalemia (serum K < 4.5)
Measured: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
hemodynamic parameters
hemodynamic parameters (blood pressure, heart rate, central venous pressure, cardiac output, SvO2)
Measured: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
inotropics, vasopressor requirement
inotropics, vasopressor requirement
Measured: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
Myocardial injury marker
serum concentration of CK-MB, Troponin (i)as a marker for myocaridial injury
Measured: 2, 24, 48 hour after the end of surgery
Left ventricular function
left ventricular function determined by Tei index, ejection fraction of preoperative, intraoperative, postoperative echocardiography
Measured: 72 hour before, during (immediate after grafting), 72 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 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
- Investigators
- Hyun Sung Cho, MD, PhD, Principal investigator, Samsung Medical CenterWon Ho Kim, MD, Principal investigator, Samsung Medical CenterYoung Tak Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572454
- Sponsor's protocol ID
- 2012-02-012-001
- Status last verified
- Dec 2013
- First submitted
- 4 Apr 2012
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Serum Potassium Concentration, Antiarrhythmic Effect, and Myocardial Protective Effect Between Dexmedetomidine and Remifentanil Infusion in Patients Undergoing Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01572454
- Acronym / sponsor ID
- 2012-02-012-001
- Conditions
- Coronary Artery Bypass Graft, Hypokalemia, Cardiac Arrhythmia, Dexmedetomidine, Remifentanil
- Keywords
- coronary artery bypass graft, hypokalemia, cardiac arrhythmia, dexmedetomidine, remifentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Apr 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.
We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients undergoing off-pump coronary artery bypass graft, and trying compare these effects with those of remifentanil infusion.
Detailed description
Alpha2-adrenergic agonist, dexmedetomidine, is recently used for sedation, analgesia or adjuvant to general anesthesia. Postsynaptic activation of alpha2 adrenoceptors in the central nervous system (CNS) inhibits sympathetic activity and thus can decrease blood pressure and heart rate. The blockade of sympathetic activity decrease the neuroendocrine stress response and may decrease the incidence of hypokalemia. The hypokalemia can increase the incidence of arrythmia, especially in cardiac patients. We postulated that dexmedetomidine could decrease the neuroendocrine stress response, thus decrease arrhythmia during cardiac surgery. Furthermore, dexmedetomidine have been reported to have cardioprotective effect with previous animal studies.
Therefore, the aim of the present study is to investigate whether the intraoperative dexmedetomidine infusion can reduce the incidence of hypokalemia and arrythmia, and myocardial injury in subjects undergoing off-pump coronary artery bypass graft. We are also trying to compare these effects with those of remifentanil infusion.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidine infusionDexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery |
| Remifentanil group | Active comparator | Drug: Remifentanil infusionRemifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those undergoing off-pump coronary artery bypass graft during March, 2012 ~ February, 2013 in Samsung Medical Center
- Age between 20 and 70 yrs old
Key exclusion criteria (2 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
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 |
|---|---|---|
| Dexmedetomidine infusionAlso: DexmedetomidineDexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery | Drug | Dexmedetomidine group |
| Remifentanil infusionAlso: RemifentanilRemifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery | Drug | Remifentanil group |
Primary outcome
serum potassium concentration
Time frame: at 24 hour before anesthetic induction
serum potassium concentration at the day before anesthetic induction
serum potassium concentration
Time frame: 1 minutes before anesthetic induction
1 minutes before anesthetic induction (etomidate injection)
serum potassium concentration
Time frame: 20 minutes after start of anesthetic induction
serum potassium concentration 20 minutes after start of anesthetic induction (at the end of anesthetic induction)
serum potassium concentration
Time frame: 2 hour after the start of anesthetic induction
serum potassium concentration at 2 hour after anesthetic induction (after mammary artery dissection and graft formation)
serum potassium concentration
Time frame: 3 hour after start of anesthetic induction
serum potassium concentration at 3 hour after end of anesthetic induction (after the anastomosis of coronary graft)
6 secondary outcomes
arterial blood gas analysis results
Time frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
incidence of hypokalemia
Time frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
hemodynamic parameters
Time frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
inotropics, vasopressor requirement
Time frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
Myocardial injury marker
Time frame: 2, 24, 48 hour after the end of surgery
Left ventricular function
Time frame: 72 hour before, during (immediate after grafting), 72 hour after surgery
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 25 Dec 2013.
Related trials for Coronary Artery Bypass Graft
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
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.
Hyun Sung Cho, MD, PhD principal investigator
Samsung Medical Center
Won Ho Kim, MD principal investigator
Samsung Medical Center
Young Tak Lee, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine infusion and Remifentanil infusion in people with Coronary Artery Bypass Graft and Hypokalemia, 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 2 inclusion and 2 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 25 Dec 2013. 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?
serum potassium concentration (time frame: at 24 hour before anesthetic induction). The study lists 5 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 25 Dec 2013.