HypertensionNCT01003561
Hemodynamic Changes of Upper and Lower Extremities After Spinal Anesthesia
A study testing spinal anesthesia for surgery in people with Hypertension, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the changes of venous flow, volume, and resistance in upper (basilic v.) and lower (popliteal v.) extremities of the elderly healthy patients compared with elderly hypertensive patients who undergoing spinal anesthesia for transurethral prostatectomy. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- spinal anesthesia for surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- > 65yr men
- who undergoes spinal anesthesia for elective TURP
- normotensive/hypertensive
Who cannot join
- vascular disease
- contraindications for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Jeong-Yeon Hong, MD contact
Hae K Kil, pHD contact
South Korea1 site
Severance Hospital, Yonsei University
Seoul, 120-752
Jeong-Yeon Hong, MD, jenyhongg@yuhs.ac
Hae K Kil, pHD, hkkil@yuhs.ac
About this study
The aim of this study is to evaluate the changes of venous flow, volume, and resistance in upper (basilic v.) and lower (popliteal v.) extremities of the elderly healthy patients compared with elderly hypertensive patients who undergoing spinal anesthesia for transurethral prostatectomy.
- Conditions
- Hypertension
- Being tested
- spinal anesthesia for surgery
- Keywords
- ultrasonographic exam on upper and lower extremities
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesia for surgeryProcedure or surgery
spinal anesthesia (T10) for elective TURP surgery
| Study group | Role | What they receive |
|---|---|---|
| ultrasonographic exam | Experimental | Not described Receives: Procedure: spinal anesthesia for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow
Measured: during 30 min after spinal anesthesia
Blood volume
Measured: during 30 min after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003561
- Sponsor's protocol ID
- 2009-TURP
- Status last verified
- Oct 2009
- First submitted
- 27 Oct 2009
- Last updated
- 28 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes of Upper and Lower Extremities After Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01003561
- Acronym / sponsor ID
- 2009-TURP
- Conditions
- Hypertension
- Keywords
- ultrasonographic exam on upper and lower extremities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- First posted
- 28 Oct 2009 (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 aim of this study is to evaluate the changes of venous flow, volume, and resistance in upper (basilic v.) and lower (popliteal v.) extremities of the elderly healthy patients compared with elderly hypertensive patients who undergoing spinal anesthesia for transurethral prostatectomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasonographic exam | Experimental | Procedure: spinal anesthesia for surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- > 65yr men
- who undergoes spinal anesthesia for elective TURP
- normotensive/hypertensive
Key exclusion criteria (2 listed)
- vascular disease
- contraindications for spinal anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesia for surgeryspinal anesthesia (T10) for elective TURP surgery | Procedure or surgery | ultrasonographic exam |
Primary outcome
Blood flow
Time frame: during 30 min after spinal anesthesia
Blood volume
Time frame: during 30 min after spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2009.
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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.
Jeong-Yeon Hong, MD contact
Hae K Kil, pHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia for surgery in people with Hypertension, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-Yeon Hong, MD (jenyhongg@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow (time frame: during 30 min after spinal anesthesia). The study lists 2 primary outcomes in all. 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 28 Oct 2009.