Dexmedetomidine in Children Having Transthoracic Echocardiography

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Chloral Hydrate; Dexmedetomidine

Criteria

Inclusion Criteria:

• Outpatients scheduled to receive sedation for transthoracic echocardiography

• Subject must be a candidate for both types of anesthetic and both doses of dexmedetomidine

• Must be 3 months to 36 months of age

Exclusion Criteria:

• The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree AV block) or channelopathy (e.g. long QT).

• The subject is taking digoxin, alpha-adrenergic or beta-adrenergic agonist or antagonist (e.g., clonidine, propranolol, albuterol), anti-arrhythmic medications, or vasodilators (e.g. ACE inhibitors)

• The subject has received a dose of any other sedative within 48 hours.

• The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).

• The subject is allergic to or has a contraindication to any of the drugs used in the study.

• The subject has previously been treated under this protocol.

• The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction)

• The subject has Moyamoya disease (risk of recurrent stroke)