Echocardiographic Evaluation of the Effects of Dexmedetomidine in Diastolic Dysfunction

NCT ID: NCT02490072

Last Updated: 2015-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine group

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

normal saline

Group Type: PLACEBO_COMPARATOR

normal saline(Saline 0.9%)

Intervention Type: DRUG

Interventions

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.

Intervention Type: DRUG

normal saline(Saline 0.9%)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2015-0284

Identifier Type: -

Identifier Source: org_study_id