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

NCT ID: NCT02300649

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Dexmedetomidine group

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.

Group Type: EXPERIMENTAL

Dexmedetomidine, Transesophageal echocardiography(TEE)

Intervention Type: 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.

Control 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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DRUG

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Precedex; Saline

Eligibility Criteria

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

• Minimum Eligible Age: 20 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, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2014-0574

Identifier Type: -

Identifier Source: org_study_id