NCT03337581

Brief Summary

  1. 1.Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric.
  2. 2.Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric.
  3. 3.Pharmacokinetics after a single dose of Dexmedetomidine administered as a nasal spray in Pediatric.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
187

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 9, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

September 1, 2017

Last Update Submit

November 7, 2017

Conditions

PediatricsDexmedetomidinePharmacodynamicsPharmacokinetics

Keywords

DexmedetomidinepediatricsPharmacodynamicsPharmacokinetics

Outcome Measures

Primary Outcomes (3)

  • Acute Hemodynamic and respiratory Changes After Rapid Intravenous of Dexmedetomidine

    Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric

    up to 4 months

  • Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric

    After a single Rapid Intravenous dose of Dexmedetomidine in Pediatric，blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).

    up to 6 months

  • Pharmacokinetics of Dexmedetomidine administered as a nasal spray

    After a single dose of Dexmedetomidine administered as a nasal spray in Pediatric,blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).

    up to 6 months

Study Arms (5)

group 1.1

SHAM COMPARATOR

Normal saline group

Drug: Dexmedetomidine

group 1.2

EXPERIMENTAL

0.25μg/kg dexmedetomidine group

Drug: Dexmedetomidine

group 1.3

EXPERIMENTAL

0.5μg/kg dexmedetomidine group

Drug: Dexmedetomidine

group 1.4

EXPERIMENTAL

0.75μg/kg dexmedetomidine group

Drug: Dexmedetomidine

group 1.5

EXPERIMENTAL

1.0μg/kg dexmedetomidine group

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

see arms

group 1.1group 1.2group 1.3group 1.4group 1.5

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • selective operation of inguinal hernia repair、orthopedics operation or general surgery operation in children
  • aged 3-9 years
  • ASA I - II
  • enter the operating room by himself without parents
  • normal liver and kidney function
  • no history of anesthesia medication allergy.

You may not qualify if:

  • allergic to dexmedetomidine, similar active ingredients or excipients
  • G-6-PD deficiency
  • a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on
  • a history of use of alpha 2 receptor agonists or antagonists.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Huacheng Liu

    The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    STUDY DIRECTOR

Central Study Contacts

Fang Chen

CONTACT

+86 1395777630015254896@qq.com

Chengyu Wang

CONTACT

+861515871919615158719196@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2017

First Posted

November 9, 2017

Study Start

October 20, 2017

Primary Completion

December 1, 2018

Study Completion

July 1, 2019

Last Updated

November 9, 2017

Record last verified: 2017-08

Locations

CN(1)