NCT02523144

Brief Summary

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

July 27, 2015

Last Update Submit

July 28, 2017

Conditions

Heart Disease

Keywords

Transthoracic echocardiographyechoTTE

Outcome Measures

Primary Outcomes (1)

  • Time to sedation

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

    30 minutes

Secondary Outcomes (12)

  • Duration of sedation level >3

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

  • The number of sonographer pauses

    Participants will be followed for the duration of the procedure, average of 1 hour

  • Need for rescue dexmedetomidine

    Participants will be followed for the duration of the procedure, average of 1 hour

  • 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

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

  • +7 more secondary outcomes

Study Arms (3)

Chloral Hydrate + placebo

ACTIVE COMPARATOR

Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo

Drug: Chloral HydrateDrug: Placebo

Dexmedetomidine 2mcg/kg + placebo

ACTIVE COMPARATOR

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

Drug: DexmedetomidineDrug: Placebo

Dexmedetomidine 3mcg/kg + placebo

ACTIVE COMPARATOR

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

Drug: DexmedetomidineDrug: Placebo

Interventions

Chloral HydrateDRUG

70mg/kg chloral hydrate

Chloral Hydrate + placebo
DexmedetomidineDRUG

2mcg/kg

Dexmedetomidine 2mcg/kg + placebo
PlaceboDRUG

Flavored placebo syrup

Chloral Hydrate + placeboDexmedetomidine 2mcg/kg + placeboDexmedetomidine 3mcg/kg + placebo

Eligibility Criteria

Age3 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Children's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Chloral HydrateDexmedetomidine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jeffrey Miller, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 14, 2015

Study Start

September 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 31, 2017

Record last verified: 2017-07

Locations

CN(1)