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

G

Guangzhou Women and Children's Medical Center

Status and phase

Completed
Phase 4

Conditions

Patients for Transthoracic Echocardiography
Unknown Diagnosis

Treatments

Drug: intranasal dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02780427
Wzhang03

Details and patient eligibility

About

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.

Full 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

Enrollment

320 patients

Sex

All

Ages

1 to 24 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

320 participants in 4 patient groups

1-6 months (Group 1)
Active Comparator group
Treatment:
Drug: intranasal dexmedetomidine
7-12 months (Group 2)
Active Comparator group
Treatment:
Drug: intranasal dexmedetomidine
13-18 months (Group 3)
Active Comparator group
Treatment:
Drug: intranasal dexmedetomidine
19-24 months (Group 4)
Active Comparator group
Treatment:
Drug: intranasal dexmedetomidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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