Dexmedetomidine in Children Having Transthoracic Echocardiography

Phase 4

Completed

• Conditions: Heart Disease
• Interventions: Drug: Chloral Hydrate; Drug: Dexmedetomidine; Drug: Placebo

• Registration Number: NCT02523144
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

Detailed Description

The goal in this study is to determine if there is a significant difference in the quality of sedation between two standard sedation techniques and between two doses of dexmedetomidine for children undergoing (TTE).

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chloral Hydrate + placebo	Chloral Hydrate	Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo
Chloral Hydrate + placebo	Placebo	Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo
Dexmedetomidine 2mcg/kg + placebo	Dexmedetomidine	Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo
Dexmedetomidine 2mcg/kg + placebo	Placebo	Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo
Dexmedetomidine 3mcg/kg + placebo	Placebo	Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo
Dexmedetomidine 3mcg/kg + placebo	Dexmedetomidine	Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo

Primary Outcome Measures

Name	Time	Method
Time to sedation	30 minutes	Achieve Ramsay sedation \>3 within 30 minutes of administration of drug

Secondary Outcome Measures

Name	Time	Method
The number of sonographer pauses	Participants will be followed for the duration of the procedure, average of 1 hour	The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted
Need for rescue dexmedetomidine	Participants will be followed for the duration of the procedure, average of 1 hour	The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.
Duration of sedation level >3	Patients will be followed for the duration of the procedure, average of 1 hour
Incidence of respiratory complications	Participants will be followed for the duration of the hospital stay, average of 2 hours	Documentation of the incidence of respiratory complications
Vital sign deviations of more than 30% from baseline	Participants will be followed for the duration of the hospital stay, average of 2 hours	Documentation of the incidence of blood pressure or heart rate deviations of more than 30% from baseline. Baseline will be measured prior to sedative administration.
Post anesthesia drowsiness	Participants will be followed for the duration of the post procedure stay, average of 1 hour	Documentation of the incidence of post anesthesia drowsiness
Duration of Post Anesthesia Care Unit phase	Participants will be followed for the duration of the post procedure stay, average of 1 hour	Documentation of the stay in Post Anesthesia Care Unit in minutes
Time to oral fluid intake	Participants will be followed for the duration of the post procedure stay, average of 1 hour	Documentation of the time (in minutes) to oral fluid intake during the PACU phase
Time to discharge	Participants will be followed for the duration of the post procedure stay, average of 1 hour	Documentation of the hospital stay after completion of the TTE.
Satisfaction of parents	Up to 3 days	The satisfaction of the sedation technique will be completed by the parents by asking a series of questions during a follow-up phone call the next business day after the TTE.
Severity of respiratory complications	Participants will be followed for the duration of the hospital stay, average of 2 hours	Documentation of the severity of respiratory complications
Post anesthesia agitation	Participants will be followed for the duration of the post procedure stay, average of 1 hour	Documentation of the incidence of post anesthesia agitation

Trial Locations

Locations (1)

Shanghai Children's Hospital; 🇨🇳 Shanghai, China