Sedation Techniques for children undergoing transthoracic echocardiography (TTE).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
279
Shanghai Children's Hospital
Shanghai, China
Time to sedation
Achieve Ramsay sedation \>3 within 30 minutes of administration of drug
Time frame: 30 minutes
Duration of sedation level >3
Time frame: Patients will be followed for the duration of the procedure, average of 1 hour
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
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
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
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
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
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Flavored placebo syrup
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
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
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
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
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
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