NCT01107873

Brief Summary

The purpose of this study is to determine the changes of Dorsalis Pedis Artery Flow Pattern after Caudal Block in Children: Observational Study Using a Duplex Sonography.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

Shorter than P25 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

First Submitted

Initial submission to the registry

April 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 7, 2010

Status Verified

October 1, 2010

Enrollment Period

1 month

First QC Date

April 19, 2010

Last Update Submit

October 6, 2010

Conditions

Keywords

Twenty (ASA status I) unpremedicated children, ages 1 to 5 yr old

Outcome Measures

Primary Outcomes (1)

  • Investigation of arterial hemodynamics

    Investigation of arterial hemodynamics included peak systolic velocity \[PS\], end diastolic velocity \[ED\], mean velocity \[MV\], time-averaged maximum velocity \[TAmax\], time-averaged mean velocity \[TAmean\], pulsatility index \[PI\], volume flow \[VF\], and dorsalis pedis artery diameter \[D\].

Study Arms (1)

duplex ultrasonography

conduct duplex ultrasonography after caudal block with sevoflurane anaesthesia in children

Eligibility Criteria

Age1 Year - 5 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children patients who visit Severance hospital

You may qualify if:

  • Twenty (ASA status I) unpremedicated children, ages 1 to 5 yr old, who were scheduled for a day-case urologic surgery

You may not qualify if:

  • if there were contraindications for caudal block including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hae Keum Kil

    Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 21, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 7, 2010

Record last verified: 2010-10