Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Spinal Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Measurement of Femoral Vein Diameter.
- Who it may be relevant to
- Registry conditions: Femoral Vein Diameter, Intraoperative Hypotension, Orthopedic Surgery, Spinal Anesthesia. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Spinal Anesthesia: A Prospective Observational Study
Overview
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.
Detailed description
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.
Interventions
- Other Measurement of Femoral Vein Diameter
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 outcome measures
- Predictive ability of the transverse diameter of the right common femoral vein (RCFV) [Time frame: At end-expiration (Up to 15 minutes)]
Secondary outcome measures (3)
- Severity of post spinal hypotension [Time frame: 24 hours postoperatively]
- Incidence of adverse events [Time frame: 24 hours postoperatively]
- Requirement of rescue medications [Time frame: 24 hours postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07339475 · MS-640-2025