Using femoral vein size to predict low blood pressure after spinal anesthesia in older adults having orthopedic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will measure the transverse diameter of the right common femoral vein (RCFV) in the inguinal region by ultrasound before spinal anesthesia and track blood pressure changes during elective lower-limb orthopedic operations in patients over 60. Investigators will enroll ASA I–II patients with BMI ≤35 and record perioperative hemodynamics to determine whether a smaller or larger RCFV correlates with post-spinal hypotension. The protocol uses bedside ultrasound as a noninvasive marker of intravascular volume status and compares the RCFV measurement with observed blood pressure drops after spinal block. The work builds on obstetric data and aims to test the method's applicability in a geriatric surgical population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 60 years.
* American Society of Anesthesiologists (ASA) physical state I-II.
* Body mass index (BMI) ≤35 kg/m². Patients above this value will be excluded because obesity may cause technical difficulty and poor image quality in femoral vein ultrasound assessment.
* Elective lower-limb orthopedic surgery under spinal anesthesia.

Exclusion Criteria:

* Patients refusing to participate.
* History of psychiatric illness or seizures.
* Absolute contraindications to spinal anesthesia: infection at the puncture site, severe coagulopathy/anticoagulation \[defined as platelet count \<75,000/µL, International Normalized Ratio (INR) \>1.5, Activated Partial Thromboplastin Time (aPTT) \>1.5 times control, or the use of anticoagulants such as warfarin, heparin, low molecular weight heparin, or direct oral anticoagulants within the recommended safety interval for neuraxial anesthesia\], severe hypovolemia, increased intracranial pressure, or known allergy to local anesthetics.
* Severe cardiac disease, including left ventricular ejection fraction \<30%, Severe valvular heart disease (e.g., critical aortic stenosis), clinically significant arrhythmias (atrial fibrillation with uncontrolled ventricular rate \>120 bpm, frequent ventricular ectopy or sustained ventricular tachyarrhythmia) and congestive heart failure such as New York Heart Association (NYHA) class III-IV.
* Severe uncontrolled hypertension, defined as persistent mean arterial pressure (MAP) ≥120 mmHg or systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg despite medical therapy.
* Severe respiratory diseases (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III-IV chronic obstructive pulmonary disease, or forced vital capacity (FVC) \<50% predicted).
* Baseline bradycardia (\<50) or mean arterial blood pressure less than 60mmHg.
* Emergency surgeries.

Where it's running

• Cairo University
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Hebatullah S Abdelhamid, MD
• Email: drhebasalah593@gmail.com
• Phone: 00201044512277

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.