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Transesophageal Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia on the Cardiac Function

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ClinicalTrials.gov Identifier: NCT02300649
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Dexmedetomidine is a selective alpha-2 adrenergic agonist that can be considered as an adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its cardiovascular effect through activation of receptors in central and peripheral nervous system. The classic cardiovascular response of dexmedetomidine is the biphasic with initial short-term increase in blood pressure followed by long-lasting decrease in BP and HR. There were several reports about these hemodynamic changes of dexmedetomidine, but not the evaluation of direct effects on cardiac function. The purpose of this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant on cardiac function by using the transesophageal echocardiography.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Dexmedetomidine, Transesophageal echocardiography(TEE) Drug: Saline will be infused for 60 minutes at the same rates as dexmedetomidine group. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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Arm Intervention/treatment
Experimental: Dexmedetomidine group
Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for 10 minutes; resulting in a loading dose of 1 mcg/kg, followed by an infusion of 0.5 μg/kg/hr for 50 minutes.
Drug: Dexmedetomidine, Transesophageal echocardiography(TEE)
Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for 10 minutes; resulting in a loading dose of 1 mcg/kg, followed by an infusion of 0.5 μg/kg/hr for 50 minutes.
Other Name: Precedex

Placebo Comparator: Control group
Saline will be infused at a rate of 6 mcg/kg/hr for 10 minutes; resulting in a loading dose of 1 mcg/kg, followed by an infusion of 0.5 μg/kg/hr for 50 minutes.
Drug: Saline will be infused for 60 minutes at the same rates as dexmedetomidine group.
Other Name: Saline




Primary Outcome Measures :
  1. systolic function by TEE (fractional area change and ejection fraction) [ Time Frame: The participants will be followed for 1 hour after study drug is administered. ]
    Systolic function measured transesophageal echocardiographically by fractional area change and ejection fraction.


Secondary Outcome Measures :
  1. diastolic function by TEE (ratio between early transmitral flow (E) and mitral annular tissue velocity (E') [ Time Frame: The participants will be followed for 1 hour after study drug is administered. ]
    Diastolic function measured transesophageal echocardiographically by ratio between early transmitral flow (E) and mitral annular tissue velocity (E').



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Above 20 years of age.
  2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
  3. general anesthesia

Exclusion Criteria:

  1. severe functional liver or kidney disease
  2. diagnosed HF ( NYHA class >3)
  3. arrhythmia or received treatment with antiarrythmic drug .
  4. severe bradycardia (HR < 45 bpm) and AV block
  5. pathologic esophageal lesion (esophageal stricture or varix )
  6. pregnancy

Information from the National Library of Medicine

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): NCT02300649


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02300649     History of Changes
Other Study ID Numbers: 4-2014-0574
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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