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Completed

NCT Number: NCT02523144

Dexmedetomidine in Children Having Transthoracic Echocardiography

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

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Key information

Age range

3 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Children's Hospital

Shanghai, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chloral Hydrate

Drug

70mg/kg chloral hydrate

Dexmedetomidine

Drug

2mcg/kg

Placebo

Drug

Flavored placebo syrup

Primary outcomes

  1. Time to sedation

    Time frame: 30 minutes

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

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

    Time frame: 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

  3. Need for rescue dexmedetomidine

    Time frame: 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.

  4. Incidence of respiratory complications

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

    Documentation of the incidence of respiratory complications

  5. Vital sign deviations of more than 30% from baseline

    Time frame: 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.

  6. Post anesthesia drowsiness

    Time frame: Participants will be followed for the duration of the post procedure stay, average of 1 hour

    Documentation of the incidence of post anesthesia drowsiness

  7. Duration of Post Anesthesia Care Unit phase

    Time frame: 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

  8. Time to oral fluid intake

    Time frame: 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

  9. Time to discharge

    Time frame: 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.

  10. Satisfaction of parents

    Time frame: 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.

  11. Severity of respiratory complications

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

    Documentation of the severity of respiratory complications

  12. Post anesthesia agitation

    Time frame: Participants will be followed for the duration of the post procedure stay, average of 1 hour

    Documentation of the incidence of post anesthesia agitation

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2015
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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