Anesthesia, CaudalNCT01107873
Changes of Dorsalis Pedis Artery Flow Pattern After Caudal Block in Children: Observational Study Using a Duplex Sonography
An observational study of Anesthesia, Caudal, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years, men only
- Conditions the study is for
- Anesthesia, Caudal
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- Men only
- No healthy volunteers
- Child
Study population: children patients who visit Severance hospital
Who may be able to join
- Twenty (ASA status I) unpremedicated children, ages 1 to 5 yr old, who were scheduled for a day-case urologic surgery
Who cannot join
- 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.
About this study
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.
- Conditions
- Anesthesia, Caudal
- Keywords
- Twenty (ASA status I) unpremedicated children, ages 1 to 5 yr old
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| duplex ultrasonography | conduct duplex ultrasonography after caudal block with sevoflurane anaesthesia in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, CaudalStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Hae Keum Kil, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107873
- Sponsor's protocol ID
- 4-2010-0085
- Status last verified
- Oct 2010
- First submitted
- 19 Apr 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Dorsalis Pedis Artery Flow Pattern After Caudal Block in Children: Observational Study Using a Duplex Sonography
- ClinicalTrials.gov ID
- NCT01107873
- Acronym / sponsor ID
- 4-2010-0085
- Conditions
- Anesthesia, Caudal
- Keywords
- Twenty (ASA status I) unpremedicated children, ages 1 to 5 yr old
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| duplex ultrasonography | – | –conduct duplex ultrasonography after caudal block with sevoflurane anaesthesia in children |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children patients who visit Severance hospital
Key inclusion criteria (1 listed)
- Twenty (ASA status I) unpremedicated children, ages 1 to 5 yr old, who were scheduled for a day-case urologic surgery
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2010.
Related trials for Anesthesia, Caudal
Not yet recruitingPhase 4
Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery
Postoperative Pain, Caudal Anesthesia
RecruitingObservational study
Comparison of Erector Spinae Plane Block and Caudal Block for Postoperative Analgesia in Pediatric Patients Undergoing Orchiopexy: A Prospective Observational Study
Caudal Epidural Anesthesia, Sacral Erector Spinae Plane Block
Not yet recruitingObservational study
Comparison of The Perfusion Index and The Surgical Pleth Index in Detecting The Effectiveness of Caudal Block in Pediatrics
The Success of Caudal Block
Recruiting
Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair
Hypospadias, Caudal Block
Not yet recruiting
Comparison of Erector Spinae Plane Block and Caudal Block in Pediatric Patients Aged 1 to 8 Years Undergoing Lower Abdominal Surgery
Caudal Epidural Anesthesia, Erector Spinae Plane Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hae Keum Kil principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Caudal, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of arterial hemodynamics. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2010.