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

NCT02780427 | Completed Phase 4 DMC

• 1 other identifier: Wzhang03
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients for Transthoracic Echocardiography; Unknown Diagnosis

Keywords

Dose-Response Relationship, Drug

Outcome Measures

Primary Outcomes (3)

• The ED50 doses for intranasal dexmedetomidine

  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

  up to 0.5 hours after transthoracic echocardiography

• The ED95 doses for intranasal dexmedetomidine

  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

  up to 0.5 hours after transthoracic echocardiography

• Score of physical movement

  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

  up to 0.5 hours after transthoracic echocardiography

Secondary Outcomes (2)

• sedation induction time

  up to 2 hours after drug administration

• Wake -up time

  up to 2 hours after drug administration

Other Outcomes (3)

• heart rate

  up to 3 hours after drug administration

• Oxyhemoglobin desaturation

  up to 3 hours after drug administration

• non-invasive systolic blood pressure

  up to 3 hours after drug administration

Study Arms (4)

1-6 months (Group 1)

ACTIVE COMPARATOR

Drug: intranasal dexmedetomidine

7-12 months (Group 2)

ACTIVE COMPARATOR

Drug: intranasal dexmedetomidine

13-18 months (Group 3)

ACTIVE COMPARATOR

Drug: intranasal dexmedetomidine

19-24 months (Group 4)

ACTIVE COMPARATOR

Drug: intranasal dexmedetomidine

Interventions

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).

1-6 months (Group 1); 13-18 months (Group 3); 19-24 months (Group 4); 7-12 months (Group 2)

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Resesearch

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 23, 2016
• Study Start: August 10, 2019
• Primary Completion: January 1, 2021
• Study Completion: May 20, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

CN (1)