- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01091779
Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal Anesthesia for Transurethral Resection of the Prostate (TURP) Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive Patients
January 26, 2012 updated by: Yonsei University
Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal Anesthesia for TURP Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive Patients.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Severance hospital, Yonsei university college of medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Male patients scheduled elective transurethral surgery
Description
Inclusion Criteria:
- males (> 65 yr) were scheduled to have spinal anaesthesia for TURP
Exclusion Criteria:
- patients with peripheral vascular disease
- chronic venous insufficiency
- prior deep vein thrombosis (DVT) defined by the presence of thrombosis on duplex or the presence of ultrasonographic signs indicating a previous DVT
- body mass index >35
- prior lower limb surgery due to arterial or venous trauma
- history of diabetes or autonomic deficiency.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Hypertensive and normotensive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
venous flow velocity, blood volume flow, resistance index, pulsatility index, diameter of popliteal vein
Time Frame: 10 minutes after spinal block
|
10 minutes after spinal block
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
March 23, 2010
First Submitted That Met QC Criteria
March 23, 2010
First Posted (Estimate)
March 24, 2010
Study Record Updates
Last Update Posted (Estimate)
January 31, 2012
Last Update Submitted That Met QC Criteria
January 26, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 4-2009-0543
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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