Post Spinal Anaesthesia HypotensionNCT07497295
Ultrasound Assessment of Femoral Vein and Inferior Vena Cava Collapsibility to Predict Spinal Anesthesia-Induced Hypotension
An observational study of Post Spinal Anaesthesia Hypotension and Transurethral Resection of the Prostate (TURP), run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia is commonly used in transurethral prostate resection (TUR-P) surgeries; however, post-spinal hypotension remains a frequent and clinically significant complication, particularly in elderly patients. Early prediction of hypotension may allow timely interventions and improve patient safety. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Post Spinal Anaesthesia Hypotension, Transurethral Resection of the Prostate (TURP)
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 30 May 2026
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult male patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective transurethral resection of the prostate (TUR-P) under spinal anesthesia. All participants will be recruited from a single tertiary care center. Patients will be evaluated preoperatively, and eligible individuals who provide written informed consent will be included in the study.
Who may be able to join
- Adult patients aged 18-75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective transurethral resection of the prostate (TUR-P)
- Planned spinal anesthesia
- Ability to provide written informed consent
Who cannot join
- Refusal to participate in the study
- Body mass index (BMI) >30 kg/m²
- Use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers
- Emergency surgery
- Baseline systolic arterial blood pressure <90 mmHg or mean arterial pressure <70 mmHg
- Major peripheral vascular disease or severe cardiovascular disease
Show all 13Show fewer
- Unstable angina or left ventricular ejection fraction <40%
- Chronic respiratory disease
- Increased intra-abdominal pressure
- Autonomic nervous system disorders
- Implanted pacemaker or implantable cardioverter-defibrillator
- Anticipated difficult airway
- Cognitive impairment or inability to cooperate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Antalya Training and Research Hospital
Antalya, Muratpasa, 07030
About this study
Official title: Evaluation of Inferior Vena Cava and Femoral Vein Collapsibility Indices for Predicting Post-Spinal Hypotension in Patients Undergoing Transurethral Prostate Resection: A Prospective Observational Study
Spinal anesthesia is commonly used in transurethral prostate resection (TUR-P) surgeries; however, post-spinal hypotension remains a frequent and clinically significant complication, particularly in elderly patients. Early prediction of hypotension may allow timely interventions and improve patient safety.
This prospective observational study aims to evaluate the predictive value of preoperative ultrasound-based inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for post-spinal hypotension in patients undergoing elective TUR-P under spinal anesthesia. Before spinal anesthesia, IVC and femoral vein measurements will be obtained using ultrasonography. Hemodynamic parameters will be recorded before and after spinal anesthesia, and the occurrence of hypotension will be assessed according to predefined criteria.
The study seeks to compare the diagnostic performance of IVC-CI and FVCI in predicting post-spinal hypotension and to identify potential clinical predictors associated with hypotension in this patient population.
Read the detailed description
This study is designed as a prospective observational study conducted at the University of Health Sciences, Antalya Training and Research Hospital. The study will include adult patients scheduled for elective transurethral prostate resection (TUR-P) under spinal anesthesia.
Spinal anesthesia is frequently preferred in TUR-P procedures; however, post-spinal hypotension is a common complication, particularly in elderly patients and those with limited physiological reserve. Hypotension following spinal anesthesia is primarily caused by sympathetic blockade, leading to reduced vascular tone and venous return. Early identification of patients at risk for hypotension may enable timely preventive and therapeutic interventions and reduce perioperative morbidity.
Prior to spinal anesthesia, all eligible patients will undergo ultrasonographic assessment of the inferior vena cava (IVC) and femoral vein while in the supine position. Measurements will be performed using a convex ultrasound probe in M-mode. The maximum and minimum diameters of the IVC and femoral vein during the same respiratory cycle will be recorded, and the collapsibility indices will be calculated using standardized formulas.
No fluid preload will be administered before spinal anesthesia. Standard monitoring, including electrocardiography, oxygen saturation, and noninvasive or invasive blood pressure monitoring when clinically indicated, will be applied. Baseline heart rate and blood pressure values will be recorded immediately before spinal anesthesia. Following spinal anesthesia, hemodynamic parameters will be recorded at two-minute intervals for a total duration of 15 minutes.
Post-spinal hypotension will be defined as a systolic blood pressure less than 90 mmHg, a decrease in systolic blood pressure greater than 30% from baseline, or a mean arterial pressure below 60 mmHg. Patients will be categorized into hypotension and non-hypotension groups based on these criteria. Severe or prolonged hypotension episodes will be treated according to standard clinical practice.
The primary objective of the study is to evaluate the predictive value of the inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for post-spinal hypotension. Secondary objectives include comparing the diagnostic performance of these two indices and identifying additional clinical predictors associated with hypotension. The findings of this study may contribute to the identification of a practical and noninvasive method for predicting post-spinal hypotension in patients undergoing TUR-P.
- Keywords
- Spinal Anesthesia, Post-Spinal Hypotension, Ultrasonography, Inferior Vena Cava Collapsibility Index, Femoral Vein Collapsibility Index
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 |
|---|---|---|
| Post-Spinal Hypotension Group | Patients who develop hypotension after spinal anesthesia according to predefined hemodynamic criteria. | |
| Non-Hypotension Group | Patients who do not develop hypotension following spinal anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Post-Spinal Hypotension Using Inferior Vena Cava and Femoral Vein Collapsibility Indices
The primary outcome is the predictive value of the inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for the development of post-spinal hypotension. Hypotension is defined as a systolic blood pressure <90 mmHg, a decrease in systolic blood pressure >30% from baseline, or a mean arterial pressure <60 mmHg within 15 minutes after spinal anesthesia.
Measured: Within the first 15 minutes after spinal anesthesia
Secondary outcomes (1)
Comparison of Diagnostic Performance of IVC-CI and FVCI for Post-Spinal Hypotension
Comparison of the diagnostic performance of inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for predicting post-spinal hypotension using predefined hypotension criteria.
Measured: Within the first 15 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 Mar 2026
- Study start1 Jan 2026
- Primary completion15 Apr 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal Anaesthesia 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nilgun Kavrut Ozturk, Antalya Training and Research Hospital
- Investigators
- Kerem Inanoglu, Medical Doctor, Study director, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497295
- Sponsor's protocol ID
- 4/20
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inferior Vena Cava and Femoral Vein Collapsibility Indices for Predicting Post-Spinal Hypotension in Patients Undergoing Transurethral Prostate Resection: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07497295
- Acronym / sponsor ID
- 4/20
- Keywords
- Spinal Anesthesia, Post-Spinal Hypotension, Ultrasonography, Inferior Vena Cava Collapsibility Index, Femoral Vein Collapsibility Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 27 Mar 2026 (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 commonly used in transurethral prostate resection (TUR-P) surgeries; however, post-spinal hypotension remains a frequent and clinically significant complication, particularly in elderly patients. Early prediction of hypotension may allow timely interventions and improve patient safety.
This prospective observational study aims to evaluate the predictive value of preoperative ultrasound-based inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for post-spinal hypotension in patients undergoing elective TUR-P under spinal anesthesia. Before spinal anesthesia, IVC and femoral vein measurements will be obtained using ultrasonography. Hemodynamic parameters will be recorded before and after spinal anesthesia, and the occurrence of hypotension will be assessed according to predefined criteria.
The study seeks to compare the diagnostic performance of IVC-CI and FVCI in predicting post-spinal hypotension and to identify potential clinical predictors associated with hypotension in this patient population.
Detailed description
This study is designed as a prospective observational study conducted at the University of Health Sciences, Antalya Training and Research Hospital. The study will include adult patients scheduled for elective transurethral prostate resection (TUR-P) under spinal anesthesia.
Spinal anesthesia is frequently preferred in TUR-P procedures; however, post-spinal hypotension is a common complication, particularly in elderly patients and those with limited physiological reserve. Hypotension following spinal anesthesia is primarily caused by sympathetic blockade, leading to reduced vascular tone and venous return. Early identification of patients at risk for hypotension may enable timely preventive and therapeutic interventions and reduce perioperative morbidity.
Prior to spinal anesthesia, all eligible patients will undergo ultrasonographic assessment of the inferior vena cava (IVC) and femoral vein while in the supine position. Measurements will be performed using a convex ultrasound probe in M-mode. The maximum and minimum diameters of the IVC and femoral vein during the same respiratory cycle will be recorded, and the collapsibility indices will be calculated using standardized formulas.
No fluid preload will be administered before spinal anesthesia. Standard monitoring, including electrocardiography, oxygen saturation, and noninvasive or invasive blood pressure monitoring when clinically indicated, will be applied. Baseline heart rate and blood pressure values will be recorded immediately before spinal anesthesia. Following spinal anesthesia, hemodynamic parameters will be recorded at two-minute intervals for a total duration of 15 minutes.
Post-spinal hypotension will be defined as a systolic blood pressure less than 90 mmHg, a decrease in systolic blood pressure greater than 30% from baseline, or a mean arterial pressure below 60 mmHg. Patients will be categorized into hypotension and non-hypotension groups based on these criteria. Severe or prolonged hypotension episodes will be treated according to standard clinical practice.
The primary objective of the study is to evaluate the predictive value of the inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for post-spinal hypotension. Secondary objectives include comparing the diagnostic performance of these two indices and identifying additional clinical predictors associated with hypotension. The findings of this study may contribute to the identification of a practical and noninvasive method for predicting post-spinal hypotension in patients undergoing TUR-P.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Spinal Hypotension Group | – | –Patients who develop hypotension after spinal anesthesia according to predefined hemodynamic criteria. |
| Non-Hypotension Group | – | –Patients who do not develop hypotension following spinal anesthesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult male patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective transurethral resection of the prostate (TUR-P) under spinal anesthesia. All participants will be recruited from a single tertiary care center. Patients will be evaluated preoperatively, and eligible individuals who provide written informed consent will be included in the study.
Key inclusion criteria (5 listed)
- Adult patients aged 18-75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective transurethral resection of the prostate (TUR-P)
- Planned spinal anesthesia
- Ability to provide written informed consent
Key exclusion criteria (13 listed)
- Refusal to participate in the study
- Body mass index (BMI) >30 kg/m²
- Use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers
- Emergency surgery
- Baseline systolic arterial blood pressure <90 mmHg or mean arterial pressure <70 mmHg
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
Prediction of Post-Spinal Hypotension Using Inferior Vena Cava and Femoral Vein Collapsibility Indices
Time frame: Within the first 15 minutes after spinal anesthesia
The primary outcome is the predictive value of the inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for the development of post-spinal hypotension. Hypotension is defined as a systolic blood pressure <90 mmHg, a decrease in systolic blood pressure >30% from baseline, or a mean arterial pressure <60 mmHg within 15 minutes after spinal anesthesia.
1 secondary outcome
Comparison of Diagnostic Performance of IVC-CI and FVCI for Post-Spinal Hypotension
Time frame: Within the first 15 minutes after 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 24 Sep 2026.
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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.
Kerem Inanoglu, Medical Doctor study director
University of Health Sciences, Antalya Training and Research Hospital
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 Post Spinal Anaesthesia Hypotension and Transurethral Resection of the Prostate (TURP), run by Antalya Training and Research 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 5 inclusion and 13 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 24 Sep 2026. 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?
Prediction of Post-Spinal Hypotension Using Inferior Vena Cava and Femoral Vein Collapsibility Indices (time frame: Within the first 15 minutes after spinal anesthesia). 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 24 Sep 2026.