Completed

NCT Number: NCT02780427

ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study

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.

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Key information

Conditions

Patients for Transthoracic Echocardiography Unknown Diagnosis

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology of Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510000, China

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Intranasal dexmedetomidine

Drug

Phase 1, Children received a bolus of intranasal dexmedetomidine which adjusted by the "Dixon up-and-down method for TEE study. The first child received 2.5 mcg/kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose varied by 0.1 mcg/kg according to the up-and-down method 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 0.25 mcg/kg of intranasal dexmedetomidine consistent with the re-estimated standard deviation (SD).

Primary outcomes

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
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
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.
- No movement
- Occasional, slight movement
- Frequent, slight movement
- Vigorous movement limited to extremities
- Vigorous movement, including torso and head

Secondary outcomes

sedation induction time

Time frame: up to 2 hours after drug administration

Successful sedation was defined as an MOAA/S of between 0 and 3, and sedation induction time was defined as the time from drug administration to the onset of satisfactory sedation
Wake -up time

Time frame: up to 2 hours after drug administration

Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke

Other outcomes

heart rate

Time frame: up to 3 hours after drug administration

Bradycardia was defined as a reduction in heart rate more than 20% from the baseline values
Oxyhemoglobin desaturation

Time frame: up to 3 hours after drug administration

Significant Oxyhemoglobin desaturation was defined as < 90%.
non-invasive systolic blood pressure

Time frame: up to 3 hours after drug administration

Hypotension was defined as a reduction in systolic blood pressure more than 20% from the baseline values

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2022
First posted: May 23, 2016
Registry last updated: Oct 10, 2022

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.