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Completed

NCT Number: NCT02300649

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

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.

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Key information

Conditions

Anesthesia

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dexmedetomidine, Transesophageal echocardiography(TEE)

Drug

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

Saline will be infused for 60 minutes at the same rates as dexmedetomidine group.

Drug

Other names: Saline

Primary outcomes

  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 outcomes

  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').

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2014
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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