Echocardiographic Evaluation of the Effects of Dexmedetomidine in Diastolic Dysfunction

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.

Study Overview

• Status: Completed
• Conditions: Under General Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: normal saline(Saline 0.9%)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion 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' ≦ 8 in preoperative echocardiographic evaluation.

1. severe functional liver or kidney disease
2. diagnosed HF (LV ejection fraction <50% , or wall motion abnormality)
3. arrhythmia or received treatment with antiarrythmic drug .
4. severe bradycardia(HR < 45 bpm) and AV block 6. pathologic esophageal lesion (esophageal stricture or varix ) 7. pregnancy 8. severe chronic obstructive lung disease.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group	Drug: Dexmedetomidine; 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.
Placebo Comparator: normal saline	Drug: normal saline(Saline 0.9%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biventricular diastolic function	E/e'estimated by using tissue Doppler 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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tei-index (myocardial performance index)	tissue Doppler image-derived myocardial performance	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)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Estimate): August 10, 2015
• Last Update Submitted That Met QC Criteria: August 6, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 4-2015-0284