Comparison of Dexmedetomidine and Remifentanil Infusion During CABG
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| ClinicalTrials.gov Identifier: NCT01572454 |
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Recruitment Status :
Completed
First Posted : April 6, 2012
Last Update Posted : December 25, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Bypass Graft Hypokalemia Cardiac Arrhythmia Dexmedetomidine Remifentanil | Drug: Dexmedetomidine infusion Drug: Remifentanil infusion | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 77 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| 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 |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dexmedetomidine group
Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
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Drug: Dexmedetomidine infusion
Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
Other Name: Dexmedetomidine |
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Active Comparator: Remifentanil group
Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
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Drug: Remifentanil infusion
Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
Other Name: Remifentanil |
- 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)
- 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 ]arterial blood gas analysis results
- incidence of hypokalemia [ Time Frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction ]incidence of hypokalemia (serum K < 3.5) incidence of hypokalemia (serum K < 4.5)
- hemodynamic parameters [ Time Frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction ]hemodynamic parameters (blood pressure, heart rate, central venous pressure, cardiac output, SvO2)
- inotropics, vasopressor requirement [ Time Frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction ]inotropics, vasopressor requirement
- Myocardial injury marker [ Time Frame: 2, 24, 48 hour after the end of surgery ]serum concentration of CK-MB, Troponin (i)as a marker for myocaridial injury
- Left ventricular function [ Time Frame: 72 hour before, during (immediate after grafting), 72 hour after surgery ]left ventricular function determined by Tei index, ejection fraction of preoperative, intraoperative, postoperative echocardiography
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| Ages Eligible for Study: | 20 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Those undergoing off-pump coronary artery bypass graft during March, 2012 ~ February, 2013 in Samsung Medical Center
- Age between 20 and 70 yrs old
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572454
| Korea, Republic of | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of, 135-710 | |
| Principal Investigator: | Hyun Sung Cho, MD, PhD | Samsung Medical Center | |
| Principal Investigator: | Won Ho Kim, MD | Samsung Medical Center | |
| Principal Investigator: | Young Tak Lee, MD, PhD | Samsung Medical Center |
| Responsible Party: | Hyun Sung Cho, Professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01572454 History of Changes |
| Other Study ID Numbers: |
2012-02-012-001 |
| First Posted: | April 6, 2012 Key Record Dates |
| Last Update Posted: | December 25, 2013 |
| Last Verified: | December 2013 |
Keywords provided by Hyun Sung Cho, Samsung Medical Center:
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coronary artery bypass graft hypokalemia cardiac arrhythmia dexmedetomidine remifentanil |
Additional relevant MeSH terms:
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Arrhythmias, Cardiac Hypokalemia Potassium Deficiency Heart Diseases Cardiovascular Diseases Pathologic Processes Water-Electrolyte Imbalance Metabolic Diseases Deficiency Diseases Malnutrition Nutrition Disorders Anesthetics Remifentanil Dexmedetomidine Central Nervous System Depressants |
Physiological Effects of Drugs Hypnotics and Sedatives Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Anesthetics, Intravenous |