Spinal Anesthesia Induced HypotensionIJV-SPINALNCT07411313
Internal Jugular Vein Ultrasound for Predicting Hypotension in Geriatric Patients Undergoing Spinal Anesthesia
An observational study of Spinal Anesthesia Induced Hypotension and Geriatric, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia-induced hypotension is a common and clinically significant complication in geriatric patients. Accurate preoperative assessment of intravascular volume status may help identify patients at risk. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia Induced Hypotension, Geriatric, Internal Jugular Vein
- What is being tested?
- Not applicable- observational study
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2024to 10 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: This study will include geriatric patients aged 65 years and older, classified as ASA I-III, scheduled for surgery under spinal anesthesia, and able to provide written informed consent. Patients with severe cardiac dysfunction, extreme obesity, or hemodynamic instability will be excluded.
Who may be able to join
- Age ≥65 years
- Scheduled to undergo surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Able and willing to provide written informed consent
Who cannot join
- Did not provide written informed consent
- Undergoing emergency surgery
- Body mass index (BMI) ≥40 kg/m²
- Receiving angiotensin-converting enzyme (ACE) inhibitors
- Pre-spinal systolic blood pressure <90 mmHg or mean arterial pressure <70 mmHg
- Unable to tolerate the supine position
- Left ventricular ejection fraction <40%
- Requiring sedoanalgesia in addition to spinal anesthesia or conversion to general anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, YENİMAHALLE, 06200
Guldeniz ARGUN, phD, +90 533 623 0405 ext. +90 3123360909, guldargun@yahoo.com
About this study
Official title: The Role of Internal Jugular Vein Ultrasonography in Predicting Hypotension in Geriatric Patients Undergoing Spinal Anesthesia: A Prospective Observational Study (Protocol ID: 2023-12/509)
Spinal anesthesia-induced hypotension is a common and clinically significant complication in geriatric patients. Accurate preoperative assessment of intravascular volume status may help identify patients at risk. Internal jugular vein (IJV) ultrasonography is a noninvasive and easily applicable bedside method that reflects venous volume status. This prospective observational study aims to evaluate the role of preoperative IJV ultrasonographic measurements in predicting hypotension following spinal anesthesia in geriatric patients. Patients aged 65 years and older undergoing elective surgery under spinal anesthesia will be included. Preoperative IJV diameter, cross-sectional area, and collapsibility index will be measured using ultrasonography. Hemodynamic parameters will be monitored intraoperatively, and the occurrence of hypotension after spinal anesthesia will be recorded. The predictive value of IJV ultrasonographic parameters for post-spinal hypotension will be analyzed
Read the detailed description
Spinal anesthesia is widely used in geriatric patients; however, hypotension following spinal anesthesia remains a frequent and clinically relevant complication in this population. Age-related physiological changes and reduced cardiovascular reserve increase susceptibility to hemodynamic instability. Therefore, identifying patients at risk of hypotension before spinal anesthesia is of clinical importance.
Assessment of intravascular volume status may contribute to predicting post-spinal hypotension. Ultrasonographic evaluation of the internal jugular vein (IJV) provides a noninvasive, bedside method reflecting venous filling and volume status. Parameters such as IJV diameter, cross-sectional area, and collapsibility index have been proposed as potential predictors of hypotension.
This prospective observational study will include patients aged 65 years and older undergoing elective surgery under spinal anesthesia. Preoperative ultrasonographic measurements of the IJV will be performed in the supine position prior to spinal anesthesia. Hemodynamic parameters, including systolic and diastolic blood pressure and heart rate, will be recorded before and after spinal anesthesia. Hypotension will be defined according to predefined criteria and documented during the intraoperative period.
The primary objective of the study is to evaluate the predictive value of preoperative IJV ultrasonographic measurements for hypotension following spinal anesthesia in geriatric patients.
- Being tested
- Not applicable- observational study
- Keywords
- Geriatric patients, Spinal anesthesia, Hypotension, Ultrasonography, Internal jugular vein
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| Hypotension Group | Geriatric patients who developed hypotension after spinal anesthesia. Receives: Other: Not applicable- observational study | |
| Non-Hypotension Group | Geriatric patients who did not develop hypotension after spinal anesthesia Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-spinal hypotension
Post-spinal hypotension was defined as a decrease of more than 20% in systolic blood pressure or mean arterial pressure from baseline, or an absolute mean arterial pressure <65 mmHg following spinal anesthesia. During the operation, systolic, diastolic, and mean arterial blood pressures and heart rate were recorded immediately after spinal anesthesia (0 minute), at 3-minute intervals during the first 15 minutes, at 15-minute intervals between 15 and 60 minutes, and at 90 minutes intraoperatively. For surgeries lasting less than 90 minutes, measurements were recorded until the end of surgery.
Measured: From spinal anesthesia administration up to 90 minutes intraoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start3 Jan 2024
- Primary completion6 Feb 2026
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Nil GÜLTEKİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411313
- Sponsor's protocol ID
- 2023-12/509
- Acronym
- IJV-SPINAL
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared. No additional data beyond what is published in the study results will be made available.
Publications
Kaur K, Sara H, Duggal G, Depuru A, Reddy A, Bansal N. The Use of the Internal Jugular Vein Collapsibility Index (IJVCI) for the Prediction of Postspinal Hypotension in Geriatric Patients Posted for Lower Limb Surgeries. Cureus. 2025 Jan 2;17(1):e76824. doi: 10.7759/cureus.76824. eCollection 2025 Jan.
PubMed 39897318Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
PubMed 20455872N P, Sinha M, Kumar M, Ramchandani S, Khetrapal M, Karoo K, Mesa BK. Role of Internal Jugular Vein Collapsibility Index in Predicting Post-spinal Hypotension in Pregnant Women Undergoing Cesarean Section: A Prospective Observational Study. Cureus. 2023 May 23;15(5):e39389. doi: 10.7759/cureus.39389. eCollection 2023 May.
PubMed 37362461Wang MK, Piticaru J, Kappel C, Mikhaeil M, Mbuagbaw L, Rochwerg B. Internal jugular vein ultrasound for the diagnosis of hypovolemia and hypervolemia in acutely ill adults: a systematic review and meta-analysis. Intern Emerg Med. 2022 Aug;17(5):1521-1532. doi: 10.1007/s11739-022-03003-y. Epub 2022 Jun 20.
PubMed 35718838Tsui BC, Wagner A, Finucane B. Regional anaesthesia in the elderly: a clinical guide. Drugs Aging. 2004;21(14):895-910. doi: 10.2165/00002512-200421140-00001.
PubMed 15554749Critchley LA. Hypotension, subarachnoid block and the elderly patient. Anaesthesia. 1996 Dec;51(12):1139-43. doi: 10.1111/j.1365-2044.1996.tb15051.x.
PubMed 9038450Hartmann B, Junger A, Klasen J, Benson M, Jost A, Banzhaf A, Hempelmann G. The incidence and risk factors for hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg. 2002 Jun;94(6):1521-9, table of contents. doi: 10.1097/00000539-200206000-00027.
PubMed 12032019Priebe HJ. The aged cardiovascular risk patient. Br J Anaesth. 2000 Nov;85(5):763-78. doi: 10.1093/bja/85.5.763.
PubMed 11094595
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Internal Jugular Vein Ultrasonography in Predicting Hypotension in Geriatric Patients Undergoing Spinal Anesthesia: A Prospective Observational Study (Protocol ID: 2023-12/509)
- ClinicalTrials.gov ID
- NCT07411313
- Acronym / sponsor ID
- IJV-SPINAL / 2023-12/509
- Keywords
- Geriatric patients, Spinal anesthesia, Hypotension, Ultrasonography, Internal jugular vein
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 13 Feb 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-induced hypotension is a common and clinically significant complication in geriatric patients. Accurate preoperative assessment of intravascular volume status may help identify patients at risk. Internal jugular vein (IJV) ultrasonography is a noninvasive and easily applicable bedside method that reflects venous volume status. This prospective observational study aims to evaluate the role of preoperative IJV ultrasonographic measurements in predicting hypotension following spinal anesthesia in geriatric patients. Patients aged 65 years and older undergoing elective surgery under spinal anesthesia will be included. Preoperative IJV diameter, cross-sectional area, and collapsibility index will be measured using ultrasonography. Hemodynamic parameters will be monitored intraoperatively, and the occurrence of hypotension after spinal anesthesia will be recorded. The predictive value of IJV ultrasonographic parameters for post-spinal hypotension will be analyzed
Detailed description
Spinal anesthesia is widely used in geriatric patients; however, hypotension following spinal anesthesia remains a frequent and clinically relevant complication in this population. Age-related physiological changes and reduced cardiovascular reserve increase susceptibility to hemodynamic instability. Therefore, identifying patients at risk of hypotension before spinal anesthesia is of clinical importance.
Assessment of intravascular volume status may contribute to predicting post-spinal hypotension. Ultrasonographic evaluation of the internal jugular vein (IJV) provides a noninvasive, bedside method reflecting venous filling and volume status. Parameters such as IJV diameter, cross-sectional area, and collapsibility index have been proposed as potential predictors of hypotension.
This prospective observational study will include patients aged 65 years and older undergoing elective surgery under spinal anesthesia. Preoperative ultrasonographic measurements of the IJV will be performed in the supine position prior to spinal anesthesia. Hemodynamic parameters, including systolic and diastolic blood pressure and heart rate, will be recorded before and after spinal anesthesia. Hypotension will be defined according to predefined criteria and documented during the intraoperative period.
The primary objective of the study is to evaluate the predictive value of preoperative IJV ultrasonographic measurements for hypotension following spinal anesthesia in geriatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotension Group | – | Other: Not applicable- observational studyGeriatric patients who developed hypotension after spinal anesthesia. |
| Non-Hypotension Group | – | Other: Not applicable- observational studyGeriatric patients who did not develop hypotension after spinal anesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study will include geriatric patients aged 65 years and older, classified as ASA I-III, scheduled for surgery under spinal anesthesia, and able to provide written informed consent. Patients with severe cardiac dysfunction, extreme obesity, or hemodynamic instability will be excluded.
Key inclusion criteria (4 listed)
- Age ≥65 years
- Scheduled to undergo surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Able and willing to provide written informed consent
Key exclusion criteria (8 listed)
- Did not provide written informed consent
- Undergoing emergency surgery
- Body mass index (BMI) ≥40 kg/m²
- Receiving angiotensin-converting enzyme (ACE) inhibitors
- Pre-spinal systolic 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | Hypotension Group, Non-Hypotension Group |
Primary outcome
Post-spinal hypotension
Time frame: From spinal anesthesia administration up to 90 minutes intraoperatively.
Post-spinal hypotension was defined as a decrease of more than 20% in systolic blood pressure or mean arterial pressure from baseline, or an absolute mean arterial pressure <65 mmHg following spinal anesthesia. During the operation, systolic, diastolic, and mean arterial blood pressures and heart rate were recorded immediately after spinal anesthesia (0 minute), at 3-minute intervals during the first 15 minutes, at 15-minute intervals between 15 and 60 minutes, and at 90 minutes intraoperatively. For surgeries lasting less than 90 minutes, measurements were recorded until the end of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Results publication: PubMed 39897318Kaur K, Sara H, Duggal G, Depuru A, Reddy A, Bansal N. The Use of the Internal Jugular Vein Collapsibility Index (IJVCI) for the Prediction of Postspinal Hypotension in Geriatric Patients Posted for Lower Limb Surgeries. Cureus. 2025 Jan 2;17(1):e76824. doi: 10.7759/cureus.76824. eCollection 2025 Jan.
- Results publication: PubMed 20455872Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
- Results publication: PubMed 37362461N P, Sinha M, Kumar M, Ramchandani S, Khetrapal M, Karoo K, Mesa BK. Role of Internal Jugular Vein Collapsibility Index in Predicting Post-spinal Hypotension in Pregnant Women Undergoing Cesarean Section: A Prospective Observational Study. Cureus. 2023 May 23;15(5):e39389. doi: 10.7759/cureus.39389. eCollection 2023 May.
- Results publication: PubMed 35718838Wang MK, Piticaru J, Kappel C, Mikhaeil M, Mbuagbaw L, Rochwerg B. Internal jugular vein ultrasound for the diagnosis of hypovolemia and hypervolemia in acutely ill adults: a systematic review and meta-analysis. Intern Emerg Med. 2022 Aug;17(5):1521-1532. doi: 10.1007/s11739-022-03003-y. Epub 2022 Jun 20.
- Results publication: PubMed 15554749Tsui BC, Wagner A, Finucane B. Regional anaesthesia in the elderly: a clinical guide. Drugs Aging. 2004;21(14):895-910. doi: 10.2165/00002512-200421140-00001.
- Results publication: PubMed 9038450Critchley LA. Hypotension, subarachnoid block and the elderly patient. Anaesthesia. 1996 Dec;51(12):1139-43. doi: 10.1111/j.1365-2044.1996.tb15051.x.
- Results publication: PubMed 12032019Hartmann B, Junger A, Klasen J, Benson M, Jost A, Banzhaf A, Hempelmann G. The incidence and risk factors for hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg. 2002 Jun;94(6):1521-9, table of contents. doi: 10.1097/00000539-200206000-00027.
- Results publication: PubMed 11094595Priebe HJ. The aged cardiovascular risk patient. Br J Anaesth. 2000 Nov;85(5):763-78. doi: 10.1093/bja/85.5.763.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared. No additional data beyond what is published in the study results will be made available.
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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.
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 and Geriatric, run by Dr Abdurrahman Yurtaslan Ankara Oncology 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aylin N Gultekin, MD (+90 538 875 65 40 ext. +90 3123360909, aylinnilkondiloglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-spinal hypotension (time frame: From spinal anesthesia administration up to 90 minutes intraoperatively.). 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 NCT07411313, which also lists 8 linked publications.
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 13 Feb 2026.