Comparison of Dexmedetomidine and Remifentanil Infusion During CABG

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyun Sung Cho, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01572454
First received: April 4, 2012
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Coronary Artery Bypass Graft
Hypokalemia
Cardiac Arrhythmia
Dexmedetomidine
Remifentanil
Drug: Dexmedetomidine infusion
Drug: Remifentanil infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • serum potassium concentration [ Time Frame: at 24 hour before anesthetic induction ] [ Designated as safety issue: Yes ]
    serum potassium concentration at the day before anesthetic induction

  • serum potassium concentration [ Time Frame: 1 minutes before anesthetic induction ] [ Designated as safety issue: Yes ]
    1 minutes before anesthetic induction (etomidate injection)

  • serum potassium concentration [ Time Frame: 20 minutes after start of anesthetic induction ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    serum potassium concentration at 3 hour after end of anesthetic induction (after the anastomosis of coronary graft)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    inotropics, vasopressor requirement

  • Myocardial injury marker [ Time Frame: 2, 24, 48 hour after the end of surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    left ventricular function determined by Tei index, ejection fraction of preoperative, intraoperative, postoperative echocardiography


Enrollment: 77
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine group
Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
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
Active Comparator: Remifentanil group
Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
Drug: Remifentanil infusion
Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
Other Name: Remifentanil

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01572454

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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
  More Information

No publications provided

Responsible Party: Hyun Sung Cho, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01572454     History of Changes
Other Study ID Numbers: 2012-02-012-001
Study First Received: April 4, 2012
Last Updated: December 24, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
coronary artery bypass graft
hypokalemia
cardiac arrhythmia
dexmedetomidine
remifentanil

Additional relevant MeSH terms:
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on July 29, 2014