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NCT Number: NCT07339475

Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Spinal Anesthesia

The study aims to assess whether the transverse diameter of the right common femoral vein (RCFV) in the inguinal region could reflect the degree of post-spinal hypotension during elective orthopedic surgery.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Spinal anesthesia is commonly used in orthopedic procedures but often results in hypotension, particularly in elderly patients due to reduced cardiovascular reserve and impaired autonomic function.

Ultrasound measurement of the right common femoral vein (RCFV) diameter has recently been proposed as a simple, non-invasive marker of intravascular volume status and a potential predictor of spinal anesthesia induced hypotension. To date, most evidence comes from obstetric populations undergoing cesarean delivery, limiting its applicability in other high-risk groups.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Measurement of Femoral Vein Diameter

Other

The transverse diameter of the right common femoral vein (RCFV) will be recorded 1 cm proximal to the junction with the great saphenous vein, at end-expiration.

Primary outcomes

  1. Predictive ability of the transverse diameter of the right common femoral vein (RCFV)

    Time frame: At end-expiration (Up to 15 minutes)

    The predictive ability of the transverse diameter of the right common femoral vein (RCFV), measured by ultrasound before spinal anesthesia, for the development of post-spinal hypotension in geriatric patients undergoing orthopedic surgery.

Secondary outcomes

  1. Severity of post spinal hypotension

    Time frame: 24 hours postoperatively

    Severity of post spinal hypotension [defined as a decrease in the mean arterial pressure (MAP) >20% from baseline]. Severity of hypotension, classified as:

    • Mild: 20-30% decrease in MAP from baseline.
    • Moderate: 30-40% decrease in MAP from baseline.
    • Severe: >40% decrease in MAP from baseline or absolute MAP <60 mmHg.
  2. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as hypotension and/or bradycardia will be recorded.

  3. Requirement of rescue medications

    Time frame: 24 hours postoperatively

    Requirement of rescue medications will be recorded.

Study contacts

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

Hebatullah S Abdelhamid, MD

CONTACT

[email protected]

00201044512277

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Spinal Anesthesia: A Prospective Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 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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