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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Anesthesia; Orthopedic Surgery; Intraoperative Hypotension; Femoral Vein Diameter
• Intervention / Treatment: Other: Measurement of Femoral Vein Diameter

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.

• Study Type: Observational
• Enrollment (Estimated): 43

Contacts and Locations

• Study Contact: Name: Hebatullah S Abdelhamid, MD; Phone Number: 00201044512277; Email: drhebasalah593@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Cairo university
    • Contact: Hebatullah S Abdelhamid, MD; Phone Number: 00201044512277; Email: drhebasalah593@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The prospective observational study will be conducted in orthopedic theatre in Cairo University Hospitals.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patients undergoing elective lower-limb orthopedic surgery under spinal anesthesia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At end-expiration (Up to 15 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as hypotension and/or bradycardia will be recorded.	24 hours postoperatively
Requirement of rescue medications	Requirement of rescue medications will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MS-640-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No