Clinical trial NCT02780427: ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study
Official title: ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients for Transthoracic Echocardiography
Unknown Diagnosis
Keywords: Dose-Response Relationship, Drug
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 320
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The median effective dose (ED50) and ED95 of intranasal dexmedetomidine as a single bolus have not been described for sedation in children undergoing transthoracic echocardiography (TEE) study. This information is important to compare agents and to determine the most effective sedative dose. The investigators performed a two-stage study to determine the ED50 and the ED95 of intranasal dexmedetomidine to investigate age-related differences in participants undergoing transthoracic echocardiography study.

Detailed description: The investigators performed a two-stage study to determine the ED50 and the ED95 of intranasal dexmedetomidine in children undergoing transthoracic echocardiography study. In phase 1, 120 participants were randomized in a Dixon-Massey study to describe the minimum local sedative dose. In phase 2, a further 160 participants were randomly allocated to receive sedation with doses in the upper dose-response range to define the ED95

Eligibility criteria: Inclusion Criteria:

* Children, aged between one and 24 months. classified as (American Society of Anesthesiologists) ASA physical status I or II, undergoing TEE were enrolled in the study.

Exclusion Criteria:

* Known allergy or hypersensitive reaction to dexmedetomidine
* Organ dysfunction, and significant developmental delays or behavior problems
* Cardiac arrhythmia
* Known. acyanotic congenital heart disease or children after cardiac interventional procedures for follow-up examination.

Primary outcomes:
measure: The ED50 doses for intranasal dexmedetomidine
timeFrame: up to 0.5 hours after transthoracic echocardiography
measure: The ED95 doses for intranasal dexmedetomidine
timeFrame: up to 0.5 hours after transthoracic echocardiography
measure: Score of physical movement
timeFrame: up to 0.5 hours after transthoracic echocardiography
Secondary outcomes:
measure: sedation induction time
timeFrame: up to 2 hours after drug administration
measure: Wake -up time
timeFrame: up to 2 hours after drug administration
Other outcomes:
measure: heart rate
timeFrame: up to 3 hours after drug administration
measure: Oxyhemoglobin desaturation
timeFrame: up to 3 hours after drug administration
measure: non-invasive systolic blood pressure
timeFrame: up to 3 hours after drug administration
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology of Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
References: