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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02523144
Other study ID # SCMCIRB-K2014057
Secondary ID
Status Completed
Phase Phase 4
First received July 27, 2015
Last updated July 28, 2017
Start date September 2014
Est. completion date May 2017

Study information

Verified date July 2017
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).


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).


Recruitment information / eligibility

Status Completed
Enrollment 279
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 3 Months to 36 Months
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chloral Hydrate
70mg/kg chloral hydrate
Dexmedetomidine
2mcg/kg
Dexmedetomidine
3mcg/kg
Placebo
Flavored placebo syrup

Locations

Country Name City State
China Shanghai Children's Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to sedation Achieve Ramsay sedation >3 within 30 minutes of administration of drug 30 minutes
Secondary Duration of sedation level >3 Patients will be followed for the duration of the procedure, average of 1 hour
Secondary The number of sonographer pauses The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted Participants will be followed for the duration of the procedure, average of 1 hour
Secondary Need for rescue dexmedetomidine The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE. Participants will be followed for the duration of the procedure, average of 1 hour
Secondary Incidence of respiratory complications Documentation of the incidence of respiratory complications Participants will be followed for the duration of the hospital stay, average of 2 hours
Secondary 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. Participants will be followed for the duration of the hospital stay, average of 2 hours
Secondary Post anesthesia drowsiness Documentation of the incidence of post anesthesia drowsiness Participants will be followed for the duration of the post procedure stay, average of 1 hour
Secondary Duration of Post Anesthesia Care Unit phase Documentation of the stay in Post Anesthesia Care Unit in minutes Participants will be followed for the duration of the post procedure stay, average of 1 hour
Secondary Time to oral fluid intake Documentation of the time (in minutes) to oral fluid intake during the PACU phase Participants will be followed for the duration of the post procedure stay, average of 1 hour
Secondary Time to discharge Documentation of the hospital stay after completion of the TTE. Participants will be followed for the duration of the post procedure stay, average of 1 hour
Secondary 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. Up to 3 days
Secondary Severity of respiratory complications Documentation of the severity of respiratory complications Participants will be followed for the duration of the hospital stay, average of 2 hours
Secondary Post anesthesia agitation Documentation of the incidence of post anesthesia agitation Participants will be followed for the duration of the post procedure stay, average of 1 hour
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