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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07339475
Enrollment
43
Registered
2026-01-14
Start date
2025-12-01
Completion date
2026-07-01
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Vein Diameter, Intraoperative Hypotension, Orthopedic Surgery, Spinal Anesthesia

Brief summary

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

OTHERMeasurement 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Predictive ability of the transverse diameter of the right common femoral vein (RCFV)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

MeasureTime frameDescription
Severity of post spinal hypotension24 hours postoperativelySeverity 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 events24 hours postoperativelyIncidence of adverse events such as hypotension and/or bradycardia will be recorded.
Requirement of rescue medications24 hours postoperativelyRequirement of rescue medications will be recorded.

Countries

Egypt

Contacts

Primary ContactHebatullah S Abdelhamid, MD
drhebasalah593@gmail.com00201044512277

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026