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

NCT07497295 | Recruiting

• 1 other identifier: 4/20
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post Spinal Anaesthesia Hypotension; Transurethral Resection of the Prostate (TURP)

Keywords

Spinal Anesthesia; Post-Spinal Hypotension; Ultrasonography; Inferior Vena Cava Collapsibility Index; Femoral Vein Collapsibility Index

Outcome Measures

Primary Outcomes (1)

• 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.

  Within the first 15 minutes after spinal anesthesia

Secondary Outcomes (1)

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

  Within the first 15 minutes after spinal anesthesia

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, Muratpasa, 07030, Turkey (Türkiye)

RECRUITING

Study Officials

• Kerem Inanoglu, Medical Doctor

  University of Health Sciences, Antalya Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Semsettin Ekingen, Medical Doctor

CONTACT

+905064839279; semsekingen@gmail.com

Kerem Inanoglu, Medical Doctor

CONTACT

+905326436531; kinanoglu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: January 1, 2026
• Primary Completion: April 15, 2026
• Study Completion: May 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)