Echocardiographic Evaluation of the Effects of Dexmedetomidine in Diastolic Dysfunction

NCT02490072 | Completed

• 1 other identifier: 4-2015-0284
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Under General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Drug: Dexmedetomidine

normal saline

PLACEBO COMPARATOR

Drug: normal saline(Saline 0.9%)

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine group

normal saline(Saline 0.9%) DRUG

normal saline

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 40 years of age.
• American Society of Anesthesiologists (ASA) Physical Status II, III.
• Preserved systolic function (Ejection fraction \> 50%)

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 3, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

KR (1)