- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411313
Internal Jugular Vein Ultrasound for Predicting Hypotension in Geriatric Patients Undergoing Spinal Anesthesia (IJV-SPINAL)
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)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Aylin N Gultekin, MD
- Phone Number: +90 3123360909 +90 538 875 65 40
- Email: aylinnilkondiloglu@gmail.com
Study Contact Backup
- Name: Guldeniz ARGUN, phD
- Phone Number: +90 3123360909 +90 533 623 0405
- Email: guldargun@yahoo.com
Study Locations
-
-
YENİMAHALLE
-
Ankara, YENİMAHALLE, Turkey (Türkiye), 06200
- Recruiting
- Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Contact:
- Guldeniz ARGUN, phD
- Phone Number: +90 3123360909 +90 533 623 0405
- Email: guldargun@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hypotension Group
Geriatric patients who developed hypotension after spinal anesthesia.
|
Not applicable- observational study
|
|
Non-Hypotension Group
Geriatric patients who did not develop hypotension after spinal anesthesia
|
Not applicable- observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From spinal anesthesia administration up to 90 minutes intraoperatively.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Klohr 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.
- Hartmann 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.
- 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.
- N P, Sinha M, Kumar M, Ramchandani S, Khetrapal M, Karoo K, et al. Role of Internal Jugular Vein Collapsibility Index in Predicting Post-spinal Hypotension in Pregnant Women Undergoing Cesarean Section: A Prospective Observational Study. Cureus. 2023;15
- Wang 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.
- Tsui 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.
- Critchley LA. Hypotension, subarachnoid block and the elderly patient. Anaesthesia. 1996 Dec;51(12):1139-43. doi: 10.1111/j.1365-2044.1996.tb15051.x.
- Priebe HJ. The aged cardiovascular risk patient. Br J Anaesth. 2000 Nov;85(5):763-78. doi: 10.1093/bja/85.5.763.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-12/509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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