Dexmedetomidine in Children Having Transthoracic Echocardiography

A Qualitative Comparison of Oral Chloral Hydrate vs 2.0 or 3.0 mcg/kg Nasal Dexmedetomidine in Children Undergoing Transthoracic Echocardiography

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

Study Overview

• Status: Completed
• Conditions: Heart Disease
• Intervention / Treatment: Drug: Chloral Hydrate; Drug: Placebo; Drug: Dexmedetomidine; Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Actual): 279
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chloral Hydrate + placebo; Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo	Drug: Chloral Hydrate; 70mg/kg chloral hydrate; Drug: Placebo; Flavored placebo syrup
Active Comparator: Dexmedetomidine 2mcg/kg + placebo; Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo	Drug: Placebo; Flavored placebo syrup; Drug: Dexmedetomidine; 2mcg/kg; Drug: Dexmedetomidine; 3mcg/kg
Active Comparator: Dexmedetomidine 3mcg/kg + placebo; Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo	Drug: Placebo; Flavored placebo syrup; Drug: Dexmedetomidine; 2mcg/kg; Drug: Dexmedetomidine; 3mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to sedation	Achieve Ramsay sedation >3 within 30 minutes of administration of drug	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of sedation level >3		Patients will be followed for the duration of the procedure, average of 1 hour
The number of sonographer pauses	The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted	Participants will be followed for the duration of the procedure, average of 1 hour
Need for rescue dexmedetomidine	The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.	Participants will be followed for the duration of the procedure, average of 1 hour
Incidence of respiratory complications	Documentation of the incidence of respiratory complications	Participants will be followed for the duration of the hospital stay, average of 2 hours
Vital sign deviations of more than 30% from baseline	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.	Participants will be followed for the duration of the hospital stay, average of 2 hours
Post anesthesia drowsiness	Documentation of the incidence of post anesthesia drowsiness	Participants will be followed for the duration of the post procedure stay, average of 1 hour
Duration of Post Anesthesia Care Unit phase	Documentation of the stay in Post Anesthesia Care Unit in minutes	Participants will be followed for the duration of the post procedure stay, average of 1 hour
Time to oral fluid intake	Documentation of the time (in minutes) to oral fluid intake during the PACU phase	Participants will be followed for the duration of the post procedure stay, average of 1 hour
Time to discharge	Documentation of the hospital stay after completion of the TTE.	Participants will be followed for the duration of the post procedure stay, average of 1 hour
Satisfaction of parents	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.	Up to 3 days
Severity of respiratory complications	Documentation of the severity of respiratory complications	Participants will be followed for the duration of the hospital stay, average of 2 hours
Post anesthesia agitation	Documentation of the incidence of post anesthesia agitation	Participants will be followed for the duration of the post procedure stay, average of 1 hour

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Jeffrey Miller, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: echo; Transthoracic echocardiography; TTE
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine; Chloral Hydrate
• Other Study ID Numbers: SCMCIRB-K2014057