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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02300649
Enrollment
30
Registered
2014-11-25
Start date
2014-09-30
Completion date
2015-01-31
Last updated
2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

DRUGDexmedetomidine, 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.

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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').

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026