About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The prospective observational study will be conducted in orthopedic theatre in Cairo University Hospitals.
Trial design
Cohort
Prospective
Treatments tested in this trial
Measurement of Femoral Vein Diameter
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Predictive ability of the transverse diameter of the right common femoral vein (RCFV)
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
Severity of post spinal hypotension
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.
Incidence of adverse events
Incidence of adverse events such as hypotension and/or bradycardia will be recorded.
Requirement of rescue medications
Requirement of rescue medications will be recorded.
Sponsors and contacts
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