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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02300649
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
4
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Dexmedetomidine, Transesophageal echocardiography(TEE)
  • Drug: Saline will be infused for 60 minutes at the same rates as dexmedetomidine group.
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

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 Names:
  • 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 Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. systolic function by TEE (fractional area change and ejection fraction) [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') [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').

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02300649
    Other Study ID Numbers:
    • 4-2014-0574
    First Posted:
    Nov 25, 2014
    Last Update Posted:
    Apr 17, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Dexmedetomidine

    Study Results

    No Results Posted as of Apr 17, 2015