NCT04376541

Brief Summary

The investigators are measuring fentanyl consumption in micrograms used during anesthesia for patients on fast track congenital cardiac surgeries

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

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

January 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

4.3 years

First QC Date

April 28, 2020

Last Update Submit

May 4, 2020

Conditions

Keywords

fast trackcongenital cardiac surgerycaudalfentanyl

Outcome Measures

Primary Outcomes (2)

  • fentanyl consumption

    amount of fentanyl used in microgram

    during the procedure (corrective surgery)

  • parents satisfaction: questionnare

    questionnare for parents satisfaction by early child communication

    after discharge from the ICU up to 1 week

Secondary Outcomes (2)

  • intensive care length of stay

    after departure from operation room until ward discharge up to 3 weeks

  • hospital length of stay

    from admission until home discharge up to 4 weeks

Study Arms (2)

early extubation

the patients extubated in O.R or within 2 hours in the ICU

Drug: Fentanyl

late extubation

the patients extubated after 2 hours from O.R

Drug: Fentanyl

Interventions

amount of fentanyl used in both groups

early extubationlate extubation

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with congenital cardiac anomaly for surgical correction from 3months to 18 years of age

You may qualify if:

  • patients diagnosed with congenital cardiac anomaly for surgical correction.
  • age limit: child 3months of age to 18 years

You may not qualify if:

  • patients with any o the following:
  • emergency surgeries
  • redo surgeries
  • complex surgeries
  • patients weight less than 3kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and intensive care and pain management

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 6, 2020

Study Start

January 1, 2016

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05