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Echocardiographic Evaluation of the Effects of Dexmedetomidine in Diastolic Dysfunction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02490072
Enrollment
40
Registered
2015-07-03
Start date
2015-07-31
Completion date
2015-08-31
Last updated
2015-08-10

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

Conditions

Under General Anesthesia

Brief summary

Dexmedetomidine is a selective α2 adrenergic agonist that can be considered a primary anesthetic, 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 shorten-increase in blood pressure followed by long-lasting decrease in BP and HR. There were several reports about these hemodynamic changs of dexmedetomidine, but not the evaluation of direct cardiac function of patients who was preexisted diastolic dysfunction. The purpose of this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant in diastolic dysfunction by using the echocardiography.

Interventions

DRUGDexmedetomidine

Formula for administrated were randomized by computer-generated randomization. The patients and anesthesiologist, who administered and conducted all this trial, were blinded to the medication allocation. An anesthesiologist, who responsible for preparation of medication was the only person, recognized of the randomization code during trial. 10 minutes after anesthetic induction, dexmedetomidine group would start the loading of dexmedetomidine (1μg/kg) during 10 minutes followed infusion of dexmedetomidine(0.5 μg/kg/min). Bispectral index was monitored continuously targeting 40±5. Target concentration of remifentanil and fresofol were controlled stepwise in accordance with BIS. Using the transesophageal echocardiography, we will evaluate the changes of cardiac function including Tei index and cardiac output.

DRUGnormal saline(Saline 0.9%)

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

The inclusion criteria included patients who estimated lateral e' velocity \<10 cm/s or septal e' velocity \<8 cm/s from the mitral annuli and averaged E/e' ≧ 9 in preoperative echocardiographic evaluation. For patients of old age (\> 60 yr) who did not undergo preoperative echocardiographic evaluation, written consent was obtained and TTE was performed to evaluate presence of diastolic dysfunction; patients with diastolic dysfunction, as previous defined, were included and those without were excluded 1. Above 40 years of age. 2. American Society of Anesthesiologists (ASA) Physical Status II, III. 3. Preserved systolic function (Ejection fraction \> 50%)

Exclusion criteria

The

Design outcomes

Primary

MeasureTime frameDescription
biventricular diastolic functionChange from baseline 10 min after induction (T1), 20 min after Dex loading (T2), 40 min after Dex loading (T3), 60 min after Dex loading(T4)E/e'estimated by using tissue Doppler index

Secondary

MeasureTime frameDescription
Tei-index (myocardial performance index)Change from baseline 10 min after induction(T1), 20 min after Dex loading (T2), 40 min after Dex loading (T3), 60 min after Dex loading(T4)tissue Doppler image-derived myocardial performance

Countries

South Korea

Outcome results

None listed

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