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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Drug: Saline will be infused for 60 minutes at the same rates as dexmedetomidine group.; Drug: Dexmedetomidine, Transesophageal echocardiography(TEE)

• Registration Number: NCT02300649
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline will be infused for 60 minutes at the same rates as dexmedetomidine group.	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.
Dexmedetomidine group	Dexmedetomidine, Transesophageal echocardiography(TEE)	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.

Primary Outcome Measures

Name	Time	Method
systolic function by TEE (fractional area change and ejection fraction)	The participants will be followed for 1 hour after study drug is administered.	Systolic function measured transesophageal echocardiographically by fractional area change and ejection fraction.

Secondary Outcome Measures

Name	Time	Method
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.	Diastolic function measured transesophageal echocardiographically by ratio between early transmitral flow (E) and mitral annular tissue velocity (E').

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of