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CompletedNCT02523144Updated Jul 31, 2017

Dexmedetomidine in Children Having Transthoracic Echocardiography

A Phase 4 interventional study of Chloral Hydrate and Dexmedetomidine in Heart Disease, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in China. Open to participants aged 3 Months to 36 Months. Per ClinicalTrials.gov, last updated 2017-07-31.

Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
279
Allocation
Randomized
Ages
3 Months to 36 Months
Sex
All
01

Study summary

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

Read the 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).

02

Conditions studied

  • Heart Disease

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Keywords

  • Transthoracic echocardiography
  • echo
  • TTE
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 279 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Months to 36 Months
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
279 participants (actual)

Study arms

  • Active comparator
    Chloral Hydrate + placebo

    Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo

    Drug: Chloral Hydrate · Drug: Placebo

  • Active comparator
    Dexmedetomidine 2mcg/kg + placebo

    Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo

    Drug: Dexmedetomidine · Drug: Placebo

  • Active comparator
    Dexmedetomidine 3mcg/kg + placebo

    Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo

    Drug: Dexmedetomidine · Drug: Placebo

Interventions

  • DrugChloral Hydrate

    70mg/kg chloral hydrate

  • DrugDexmedetomidine

    2mcg/kg

  • DrugDexmedetomidine

    3mcg/kg

  • DrugPlacebo

    Flavored placebo syrup

06

What researchers measure

Primary outcomes

  1. Time to sedation

    Achieve Ramsay sedation \>3 within 30 minutes of administration of drug

    Time frame: 30 minutes

Secondary outcomes

  1. Duration of sedation level >3

    Time frame: Patients will be followed for the duration of the procedure, average of 1 hour

  2. The number of sonographer pauses

    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

  3. Need for rescue dexmedetomidine

    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

  4. Incidence of respiratory complications

    Documentation of the incidence of respiratory complications

    Time frame: Participants will be followed for the duration of the hospital stay, average of 2 hours

  5. 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.

    Time frame: Participants will be followed for the duration of the hospital stay, average of 2 hours

  6. Post anesthesia drowsiness

    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

  7. Duration of Post Anesthesia Care Unit phase

    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

  8. Time to oral fluid intake

    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

  9. Time to discharge

    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

  10. 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.

    Time frame: Up to 3 days

  11. Severity of respiratory complications

    Documentation of the severity of respiratory complications

    Time frame: Participants will be followed for the duration of the hospital stay, average of 2 hours

  12. Post anesthesia agitation

    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

07

Study locations

1 site
  • Shanghai Children's Hospital
    Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02523144
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Sponsor
First posted
Aug 14, 2015
Start date
Sep 2014
Primary completion
May 2017
Completion
May 2017
Last update
Jul 31, 2017

Study contacts

Jeffrey Miller, MD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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