NCT02761954

Brief Summary

With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and the basilar artery (BA) after the caudal block changes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

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 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

May 2, 2016

Last Update Submit

July 10, 2018

Conditions

Pediatric Anesthesia

Keywords

regional anesthesiacaudal block

Outcome Measures

Primary Outcomes (1)

  • depression of blood flow in ACA & basilar artery after caudal block

    one hour

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

infants and neonates undergoing a infraumbilical surgery in general anesthesia with caudal block

You may qualify if:

  • opened big fontanella
  • infraumbilical surgery

You may not qualify if:

  • cardiac or cerebral disease
  • prior operation on vertebra, heart or head/brain
  • malforamtion of head or vertebra
  • closed fontanella
  • contraindication for caudal block (von-Willebrand-Syndrome, haemophilia,...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oberarzt Anästhesi-Abtl.

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 4, 2016

Study Start

January 1, 2016

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

July 11, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share