NCT07411313

Brief 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. 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2026

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

February 5, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

Geriatric patientsSpinal anesthesiaHypotensionUltrasonographyInternal jugular vein

Outcome Measures

Primary Outcomes (1)

  • 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.

    From spinal anesthesia administration up to 90 minutes intraoperatively.

Study Arms (2)

Hypotension Group

Geriatric patients who developed hypotension after spinal anesthesia.

Other: Not applicable- observational study

Non-Hypotension Group

Geriatric patients who did not develop hypotension after spinal anesthesia

Other: Not applicable- observational study

Interventions

Not applicable- observational study

Hypotension GroupNon-Hypotension Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, YENİMAHALLE, 06200, Turkey (Türkiye)

RECRUITING

Related Publications (8)

  • 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.

  • 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.

  • 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

    RESULT
  • 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.

  • 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.

  • Priebe HJ. The aged cardiovascular risk patient. Br J Anaesth. 2000 Nov;85(5):763-78. doi: 10.1093/bja/85.5.763.

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician in Anesthesiology and Reanimation

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 13, 2026

Study Start

January 3, 2024

Primary Completion

February 6, 2026

Study Completion

February 10, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations