Dexmedetomidine in Children Having Transthoracic Echocardiography

Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523144
• Other study ID #: SCMCIRB-K2014057
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2015
• Last updated: July 28, 2017
• Start date: September 2014
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 36 Months

Eligibility

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)

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases

Intervention

Drug:
• Chloral Hydrate
70mg/kg chloral hydrate
• Dexmedetomidine
2mcg/kg
• Dexmedetomidine
3mcg/kg
• Placebo
Flavored placebo syrup

Locations

Country	Name	City	State
China	Shanghai Children's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to sedation	Achieve Ramsay sedation >3 within 30 minutes of administration of drug	30 minutes
Secondary	Duration of sedation level >3		Patients will be followed for the duration of the procedure, average of 1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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