NCT02375243

Brief Summary

The aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the need for sedatives and analgesics in the immediate post-operative period in children who underwent surgical correction of complex congenital heart disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

October 25, 2014

Last Update Submit

February 11, 2017

Conditions

Deep Sedation

Outcome Measures

Primary Outcomes (1)

  • mechanical ventilation time

    To evaluate the efficacy of dexmedetomidine, administered in combination with midazolam and morphine, in reducing the time of mechanical ventilation, due to lower consumption of opioids and hypnotics and subsequent reduction of respiratory depression

    participants will be followed for the duration of ICU stay, an expected average of 5 days

Secondary Outcomes (3)

  • analgo-sedation level

    participants will be followed for the duration of ICU stay, an expected average of 5 days

  • withdrawal symptoms

    participants will be followed for the duration of ICU stay, an expected average of 5 days

  • safety of dexmedetomidine infusion as a measure of systemic pressure decrease

    participants will be followed for the duration of ICU stay, an expected average of 5 days

Study Arms (2)

cases

EXPERIMENTAL

children who receive midazolam 0.05 mg/kg/h + morphine 10 mcg/kg/h + dexmedetomidne 0.5 mcg/kg/h. Midazolam in administered until extubation, while morphine and dexmedetomidine are administered until removal of surgical drains.

Drug: dexmedetomidine

controls

NO INTERVENTION

standard care: children who receive midazolam 0.1 mg/kg/h + morphine 20 mcg/kg/h. Midazolam in administered until extubation, while morphine is administered until removal of surgical drains.

Interventions

dexmedetomidineDRUG

dexmedetomidine continous infusion 0.5 mcg/kg/h

Also known as: dexdor
cases

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bambino Gesù Children's Hospital

Rome, Rome, 00100, Italy

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Paola Cogo, doctor

    Bambino Gesù Children Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

October 25, 2014

First Posted

March 2, 2015

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

IT(1)