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

Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300649
• Other study ID #: 4-2014-0574
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: April 16, 2015
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Above 20 years of age.

2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.

3. general anesthesia

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	diastolic function by TEE (ratio between early transmitral flow (E) and mitral annular tissue velocity (E')	Diastolic function measured transesophageal echocardiographically by 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.	No