Spinal Anesthesia-Induced HypotensionNCT06749184
Predictors of Spinal Anesthesia-Induced Hypotension in Hypertensive Patients
An observational study of Spinal Anesthesia-Induced Hypotension, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate predictive factors for spinal anesthesia-induced hypotension (SASH) in hypertensive patients undergoing elective surgery. Parameters such as internal jugular vein collapsibility index, carotid intima-media thickness, and flow-mediated dilation will be assessed… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Anesthesia-Induced Hypotension
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2025to 10 Jun 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adult hypertensive patients scheduled for elective surgical procedures under spinal anesthesia at Konya City Hospital. The target population comprises patients with hypertensive patients (ASA II-III classification), who are deemed fit for elective surgery and spinal anesthesia by their clinical teams. Eligible participants will be screened based on inclusion and exclusion criteria. The study population represents a subset of hypertensive individuals with varying durations of hypertension, medication regimens, and cardiovascular profiles. Patients will be recruited from preoperative assessment clinics and surgical wards at the hospital.
Who may be able to join
- Adult hypertensive patients classified as ASA II-III risk group. Patients scheduled for elective surgeries requiring spinal anesthesia.
Who cannot join
- Presence of severe renal or hepatic failure, or severe respiratory or cardiovascular diseases.
- Contraindication to spinal anesthesia. Failure of spinal anesthesia. History of carotid surgery or presence of carotid plaques. Presence of anxiety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining Factors That Predict Hypotension Related to Spinal Anesthesia in Patients With Hypertension
This prospective observational study aims to evaluate predictive factors for spinal anesthesia-induced hypotension (SASH) in hypertensive patients undergoing elective surgery. Parameters such as internal jugular vein collapsibility index, carotid intima-media thickness, and flow-mediated dilation will be assessed using ultrasonography to determine their association with SASH. Demographic, anthropometric, and hemodynamic data will also be analyzed. The findings may improve perioperative management strategies for hypertensive patients receiving spinal anesthesia.
Read the detailed description
This study aims to investigate the relationship between carotid intima-media thickness (CIMT) and spinal anesthesia-induced hypotension (SASH) in hypertensive patients. SASH is a common side effect of spinal anesthesia, with an incidence ranging from 15% to 33%, and is associated with significant clinical consequences such as increased morbidity and mortality. CIMT is a well-established marker of atherosclerotic burden and cardiovascular risk. This study hypothesizes that CIMT may be an independent predictor of SASH in hypertensive patients. Participants will undergo preoperative CIMT measurements and standardized spinal anesthesia procedures, with hemodynamic variables and potential risk factors recorded for analysis.
- Conditions
- Spinal Anesthesia-Induced Hypotension
- Keywords
- Spinal Anesthesia, Hypotension, Hypertensive Patients, Hemodynamic Predictors
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Spinal Anesthesia-Induced Hypotension (SASH)
Percentage of patients experiencing a decrease in systolic blood pressure by 20% or more from baseline or a drop below 90 mmHg during the first 30 minutes following spinal anesthesia.
Measured: 30 minutes 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 posted27 Dec 2024
- Study start3 Jan 2025
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthesia-Induced HypotensionStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami TUTAR, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749184
- Sponsor's protocol ID
- 3.05.2024-27769
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tutar MS, Mermer HA, Oner AA, Birler AI, Mutluay YS, Satici H, Yildiz M, Kozanhan B. EXPRESS: Preoperative Corrected Carotid Flow Time Is Associated With Spinal Anesthesia-Induced Hypotension in Hypertensive Patients: A Prospective Observational Study. J Investig Med. 2026 Aug 21:10815589261483669. doi: 10.1177/10815589261483669. Online ahead of print.
PubMed 42629944
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Factors That Predict Hypotension Related to Spinal Anesthesia in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT06749184
- Acronym / sponsor ID
- 3.05.2024-27769
- Conditions
- Spinal Anesthesia-Induced Hypotension
- Keywords
- Spinal Anesthesia, Hypotension, Hypertensive Patients, Hemodynamic Predictors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 27 Dec 2024 (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.
This prospective observational study aims to evaluate predictive factors for spinal anesthesia-induced hypotension (SASH) in hypertensive patients undergoing elective surgery. Parameters such as internal jugular vein collapsibility index, carotid intima-media thickness, and flow-mediated dilation will be assessed using ultrasonography to determine their association with SASH. Demographic, anthropometric, and hemodynamic data will also be analyzed. The findings may improve perioperative management strategies for hypertensive patients receiving spinal anesthesia.
Detailed description
This study aims to investigate the relationship between carotid intima-media thickness (CIMT) and spinal anesthesia-induced hypotension (SASH) in hypertensive patients. SASH is a common side effect of spinal anesthesia, with an incidence ranging from 15% to 33%, and is associated with significant clinical consequences such as increased morbidity and mortality. CIMT is a well-established marker of atherosclerotic burden and cardiovascular risk. This study hypothesizes that CIMT may be an independent predictor of SASH in hypertensive patients. Participants will undergo preoperative CIMT measurements and standardized spinal anesthesia procedures, with hemodynamic variables and potential risk factors recorded for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult hypertensive patients scheduled for elective surgical procedures under spinal anesthesia at Konya City Hospital. The target population comprises patients with hypertensive patients (ASA II-III classification), who are deemed fit for elective surgery and spinal anesthesia by their clinical teams. Eligible participants will be screened based on inclusion and exclusion criteria. The study population represents a subset of hypertensive individuals with varying durations of hypertension, medication regimens, and cardiovascular profiles. Patients will be recruited from preoperative assessment clinics and surgical wards at the hospital.
Key inclusion criteria (1 listed)
- Adult hypertensive patients classified as ASA II-III risk group. Patients scheduled for elective surgeries requiring spinal anesthesia.
Key exclusion criteria (2 listed)
- Presence of severe renal or hepatic failure, or severe respiratory or cardiovascular diseases.
- Contraindication to spinal anesthesia. Failure of spinal anesthesia. History of carotid surgery or presence of carotid plaques. Presence of anxiety.
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
Incidence of Spinal Anesthesia-Induced Hypotension (SASH)
Time frame: 30 minutes after spinal anesthesia.
Percentage of patients experiencing a decrease in systolic blood pressure by 20% or more from baseline or a drop below 90 mmHg during the first 30 minutes following spinal anesthesia.
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 17 Nov 2025.
- Derived from this study: PubMed 42629944Tutar MS, Mermer HA, Oner AA, Birler AI, Mutluay YS, Satici H, Yildiz M, Kozanhan B. EXPRESS: Preoperative Corrected Carotid Flow Time Is Associated With Spinal Anesthesia-Induced Hypotension in Hypertensive Patients: A Prospective Observational Study. J Investig Med. 2026 Aug 21:10815589261483669. doi: 10.1177/10815589261483669. Online ahead of print.
- Individual participant dataSharing planned: No
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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-Induced Hypotension, run by Konya City Hospital 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 1 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: finished, as of the sponsor's last update on 17 Nov 2025. 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?
Incidence of Spinal Anesthesia-Induced Hypotension (SASH) (time frame: 30 minutes after spinal anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06749184, which also lists 1 linked publication.
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 17 Nov 2025.