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

NCT02780427 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2022-10-10

No results posted yet for this study

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

Interventions

DRUG

intranasal dexmedetomidine

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).

Sponsors & Collaborators

  • Guangzhou Women and Children's Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-10
Primary Completion
2021-01-01
Completion
2022-05-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02780427 on ClinicalTrials.gov