Heart Disease
Conditions
Keywords
Transthoracic echocardiography, echo, TTE
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).
Interventions
DRUGChloral Hydrate
70mg/kg chloral hydrate
DRUGDexmedetomidine
2mcg/kg
DRUGPlacebo
Flavored placebo syrup
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Months to 36 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to sedation | 30 minutes | Achieve Ramsay sedation \>3 within 30 minutes of administration of drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 sedation level >3 | Patients will be followed for the duration of the procedure, average of 1 hour | — |
| 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 |
| 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 |
Countries
China
Outcome results
None listed