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

NCT02300649 | Completed

• 1 other identifier: 4-2014-0574
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• systolic function by TEE (fractional area change and ejection fraction)

  Systolic function measured transesophageal echocardiographically by fractional area change and ejection fraction.

  The participants will be followed for 1 hour after study drug is administered.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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.

Drug: Dexmedetomidine, Transesophageal echocardiography(TEE)

Control group

PLACEBO COMPARATOR

Saline 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.

Drug: Saline will be infused for 60 minutes at the same rates as dexmedetomidine group.

Interventions

Dexmedetomidine, Transesophageal echocardiography(TEE) DRUG

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.

Also known as: Precedex

Dexmedetomidine group

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

Also known as: Saline

Control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 20 years of age.
• American Society of Anesthesiologists (ASA) Physical Status I, II, III.
• general anesthesia

You may not qualify if:

• severe functional liver or kidney disease
• diagnosed HF ( NYHA class \>3)
• arrhythmia or received treatment with antiarrythmic drug .
• severe bradycardia (HR \< 45 bpm) and AV block
• pathologic esophageal lesion (esophageal stricture or varix )
• pregnancy

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 25, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

KR (1)