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NCT Number: NCT07497295

Ultrasound Assessment of Femoral Vein and Inferior Vena Cava Collapsibility to Predict Spinal Anesthesia-Induced Hypotension

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Health Sciences, Antalya Training and Research Hospital

Antalya, Muratpasa, 07030, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison of Diagnostic Performance of IVC-CI and FVCI for Post-Spinal Hypotension

    Time frame: Within the first 15 minutes after spinal anesthesia

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kerem Inanoglu, Medical Doctor

CONTACT

[email protected]

+905326436531

Semsettin Ekingen, Medical Doctor

CONTACT

[email protected]

+905064839279

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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