Spinal Anesthesia EvaluationNCT05332379
Regional Hemodynamic Parameter Changes After Spinal Anesthesia
An observational study of Spinal Anesthesia Evaluation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia is a regional anesthesia method used for surgical procedures generally involving the lower abdominal area, perineum, and lower extremities. Various tests are performed to evaluate the block level after spinal anesthesia, incluyding pinprick test, cold application, and motor examination. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Anesthesia Evaluation
- What is being tested?
- Pulsed Wave Doppler USG examination
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 20 Jul 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective operation with spinal anesthesia will be recruited for the study. Posterior tibial artery velocities (peak systolic, end-diastolic) and the vessel diameters will be measured via USG Pulsed Wave Doppler mode. Three measurements will be performed: before spinal anesthesia, at the 5th and at the 10th minutes after the subarachnoid injection. The patients' sensory and motor examinations will be performed as well.
Who may be able to join
- Elective surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) I-II physical status
Who cannot join
- Contraindication for spinal anesthesia
- ASA physical status >II
- Vasoactive drug usage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul, Pendik, 34899
About this study
Official title: Measurement of Regional Hemodynamic Parameters Before and After Spinal Anesthesia with Doppler USG
Spinal anesthesia is a regional anesthesia method used for surgical procedures generally involving the lower abdominal area, perineum, and lower extremities. Various tests are performed to evaluate the block level after spinal anesthesia, incluyding pinprick test, cold application, and motor examination. These tests are performed to check whether the pain, sympathetic and motor nerve fibers are affected, respectively, after the block; and good communication with the patient is important here. However, it is extremely difficult to evaluate these tests in pediatric, geriatric, mentally retarded or uncooperative patients.
Sympathectomy can be used as a criterion to evaluate the success of the block that occurs after the spinal anesthesia procedure. Sympathetic nerve fibers are the first to be affected by the block, and the success of the block can be evaluated with the revealed sympathectomy. Sympathectomy in the lower extremities after spinal block increases arterial blood flow. This increase in blood flow can be detected by the Pulsed Wave Doppler feature of USG.
- Conditions
- Spinal Anesthesia Evaluation
- Being tested
- Pulsed Wave Doppler USG examination
- Keywords
- Spinal anesthesia, Test, Pulsed Wave Doppler, Sympathectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Wave Doppler USG examinationDiagnostic test
Pulsed Wave Doppler USG examination of the posterior tibial artery on the left or right lower extremity will be performed before spinal anesthesia, at the 5th and 10th minutes after the spinal anesthesia. Blood flow velocities and vessel diameters will be measured.
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial velocity changes
Posterior tibial artery velocities (peak systolic, end-diastolic) and vessel diameters will be measured after the spinal anesthesia procedure.
Measured: At the 5th and 10th minutes after the spinal anesthesia procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Apr 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthesia EvaluationStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Abdullayev, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332379
- Sponsor's protocol ID
- 09.2021.1406
- Status last verified
- Oct 2023
- First submitted
- 11 Apr 2022
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Regional Hemodynamic Parameters Before and After Spinal Anesthesia with Doppler USG
- ClinicalTrials.gov ID
- NCT05332379
- Acronym / sponsor ID
- 09.2021.1406
- Conditions
- Spinal Anesthesia Evaluation
- Keywords
- Spinal anesthesia, Test, Pulsed Wave Doppler, Sympathectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 18 Apr 2022 (actual)
- 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.
Spinal anesthesia is a regional anesthesia method used for surgical procedures generally involving the lower abdominal area, perineum, and lower extremities. Various tests are performed to evaluate the block level after spinal anesthesia, incluyding pinprick test, cold application, and motor examination. These tests are performed to check whether the pain, sympathetic and motor nerve fibers are affected, respectively, after the block; and good communication with the patient is important here. However, it is extremely difficult to evaluate these tests in pediatric, geriatric, mentally retarded or uncooperative patients.
Sympathectomy can be used as a criterion to evaluate the success of the block that occurs after the spinal anesthesia procedure. Sympathetic nerve fibers are the first to be affected by the block, and the success of the block can be evaluated with the revealed sympathectomy. Sympathectomy in the lower extremities after spinal block increases arterial blood flow. This increase in blood flow can be detected by the Pulsed Wave Doppler feature of USG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective operation with spinal anesthesia will be recruited for the study. Posterior tibial artery velocities (peak systolic, end-diastolic) and the vessel diameters will be measured via USG Pulsed Wave Doppler mode. Three measurements will be performed: before spinal anesthesia, at the 5th and at the 10th minutes after the subarachnoid injection. The patients' sensory and motor examinations will be performed as well.
Key inclusion criteria (2 listed)
- Elective surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) I-II physical status
Key exclusion criteria (3 listed)
- Contraindication for spinal anesthesia
- ASA physical status >II
- Vasoactive drug usage
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 |
|---|---|---|
| Pulsed Wave Doppler USG examinationPulsed Wave Doppler USG examination of the posterior tibial artery on the left or right lower extremity will be performed before spinal anesthesia, at the 5th and 10th minutes after the spinal anesthesia. Blood flow velocities and vessel diameters will be measured. | Diagnostic test | – |
Primary outcome
Arterial velocity changes
Time frame: At the 5th and 10th minutes after the spinal anesthesia procedure
Posterior tibial artery velocities (peak systolic, end-diastolic) and vessel diameters will be measured after the spinal anesthesia procedure.
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 31 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia Evaluation, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 31 Dec 2024. 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 Turkey (Türkiye). 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?
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?
Arterial velocity changes (time frame: At the 5th and 10th minutes after the spinal anesthesia procedure). 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 31 Dec 2024.