ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- The ED95 doses for intranasal dexmedetomidine
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Month to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1-6 months (Group 1)
Intervention: intranasal dexmedetomidine (Drug)
7-12 months (Group 2)
Intervention: intranasal dexmedetomidine (Drug)
13-18 months (Group 3)
Intervention: intranasal dexmedetomidine (Drug)
19-24 months (Group 4)
Intervention: intranasal dexmedetomidine (Drug)
Outcomes
Primary Outcomes
The ED95 doses for intranasal dexmedetomidine
Time Frame: up to 0.5 hours after transthoracic echocardiography
Phase 2 was a dose-escalation study. After interim analysis of the phase 1 results, four dose levels above the calculated ED50 were defined. Dose spacing was set at 0.3 mcg/kg of intranasal dexmedetomidine consistent with the re-estimated standard deviation (SD). Defined levels were set at about 2.5, 2.75, 3.0, and 3.25 mcg/kg of intranasal dexmedetomidine. Criteria for success and failure were identical to those in phase 1. Successful sedation was defined as a MOAA/S score between 0-3 and allowed the acquisition of clinically adequate diagnostic-quality images, while failure was defined as a MOAA/S score \>3 within 45 minutes or clinically adequate diagnostic-quality images could not be acquired
The ED50 doses for intranasal dexmedetomidine
Time Frame: up to 0.5 hours after transthoracic echocardiography
Phase 1: The starting dose of dexmedetomidine was 2.5 mcg/kg. These doses varied by 0.1 mcg/kg, according to the up-and-down method 18. If the detected MOAA/S score was \>3 within 45 minutes after intranasal administration, or clinically adequate diagnostic-quality images could not be acquired, sedation was considered a failure; and the dexmedetomidine dose was increased by 0.1 mcg/kg in the next patient of the same age group. In contrast, if the detected MOAA/S score was ≤3 and the acquisition of clinically adequate diagnostic-quality images was possible, the sedation was considered successful; and the dexmedetomidine dose was decreased by 0.1 mcg/kg in the next patient o
Score of physical movement
Time Frame: up to 0.5 hours after transthoracic echocardiography
Movement score was recorded by sonographers who were blinded to the sedative regimen. 1. No movement 2. Occasional, slight movement 3. Frequent, slight movement 4. Vigorous movement limited to extremities 5. Vigorous movement, including torso and head
Secondary Outcomes
- sedation induction time(up to 2 hours after drug administration)
- Wake -up time(up to 2 hours after drug administration)
Investigators
Wenhua Zhang
Director, Clinical Resesearch
Guangzhou Women and Children's Medical Center