Back to resultsDexmedetomidine in Children Having Transthoracic Echocardiography
Primary Purpose
Heart Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Chloral Hydrate
Dexmedetomidine
Dexmedetomidine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Disease focused on measuring Transthoracic echocardiography, echo, TTE
Eligibility 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)
Sites / Locations
- Shanghai Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Chloral Hydrate + placebo
Dexmedetomidine 2mcg/kg + placebo
Dexmedetomidine 3mcg/kg + placebo
Arm Description
Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo
Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo
Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo
Outcomes
Primary Outcome Measures
Time to sedation
Achieve Ramsay sedation >3 within 30 minutes of administration of drug
Secondary Outcome Measures
Duration of sedation level >3
The number of sonographer pauses
The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted
Need for rescue dexmedetomidine
The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.
Incidence of respiratory complications
Documentation of the incidence of respiratory complications
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.
Post anesthesia drowsiness
Documentation of the incidence of post anesthesia drowsiness
Duration of Post Anesthesia Care Unit phase
Documentation of the stay in Post Anesthesia Care Unit in minutes
Time to oral fluid intake
Documentation of the time (in minutes) to oral fluid intake during the PACU phase
Time to discharge
Documentation of the hospital stay after completion of the TTE.
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.
Severity of respiratory complications
Documentation of the severity of respiratory complications
Post anesthesia agitation
Documentation of the incidence of post anesthesia agitation
Full Information
NCT ID
NCT02523144
First Posted
July 27, 2015
Last Updated
July 28, 2017
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT02523144
Brief Title
Dexmedetomidine in Children Having Transthoracic Echocardiography
Official Title
A Qualitative Comparison of Oral Chloral Hydrate vs 2.0 or 3.0 mcg/kg Nasal Dexmedetomidine in Children Undergoing Transthoracic Echocardiography
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
Transthoracic echocardiography, echo, TTE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
279 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chloral Hydrate + placebo
Arm Type
Active Comparator
Arm Description
Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo
Arm Title
Dexmedetomidine 2mcg/kg + placebo
Arm Type
Active Comparator
Arm Description
Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo
Arm Title
Dexmedetomidine 3mcg/kg + placebo
Arm Type
Active Comparator
Arm Description
Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo
Intervention Type
Drug
Intervention Name(s)
Chloral Hydrate
Intervention Description
70mg/kg chloral hydrate
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
2mcg/kg
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
3mcg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Flavored placebo syrup
Primary Outcome Measure Information:
Title
Time to sedation
Description
Achieve Ramsay sedation >3 within 30 minutes of administration of drug
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Duration of sedation level >3
Time Frame
Patients will be followed for the duration of the procedure, average of 1 hour
Title
The number of sonographer pauses
Description
The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted
Time Frame
Participants will be followed for the duration of the procedure, average of 1 hour
Title
Need for rescue dexmedetomidine
Description
The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.
Time Frame
Participants will be followed for the duration of the procedure, average of 1 hour
Title
Incidence of respiratory complications
Description
Documentation of the incidence of respiratory complications
Time Frame
Participants will be followed for the duration of the hospital stay, average of 2 hours
Title
Vital sign deviations of more than 30% from baseline
Description
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.
Time Frame
Participants will be followed for the duration of the hospital stay, average of 2 hours
Title
Post anesthesia drowsiness
Description
Documentation of the incidence of post anesthesia drowsiness
Time Frame
Participants will be followed for the duration of the post procedure stay, average of 1 hour
Title
Duration of Post Anesthesia Care Unit phase
Description
Documentation of the stay in Post Anesthesia Care Unit in minutes
Time Frame
Participants will be followed for the duration of the post procedure stay, average of 1 hour
Title
Time to oral fluid intake
Description
Documentation of the time (in minutes) to oral fluid intake during the PACU phase
Time Frame
Participants will be followed for the duration of the post procedure stay, average of 1 hour
Title
Time to discharge
Description
Documentation of the hospital stay after completion of the TTE.
Time Frame
Participants will be followed for the duration of the post procedure stay, average of 1 hour
Title
Satisfaction of parents
Description
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.
Time Frame
Up to 3 days
Title
Severity of respiratory complications
Description
Documentation of the severity of respiratory complications
Time Frame
Participants will be followed for the duration of the hospital stay, average of 2 hours
Title
Post anesthesia agitation
Description
Documentation of the incidence of post anesthesia agitation
Time Frame
Participants will be followed for the duration of the post procedure stay, average of 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Miller, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Children's Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Dexmedetomidine in Children Having Transthoracic Echocardiography
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