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

NCT07339475 | Recruiting

• 1 other identifier: MS-640-2025
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Severity of post spinal hypotension

  24 hours postoperatively

• Incidence of adverse events

  24 hours postoperatively

• Requirement of rescue medications

  24 hours postoperatively

Study Arms (1)

Study group

Patients undergoing elective lower-limb orthopedic surgery under spinal anesthesia

Other: Measurement of Femoral Vein Diameter

Interventions

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.

Study group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

Central Study Contacts

Hebatullah S Abdelhamid, MD

CONTACT

00201044512277; drhebasalah593@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical Critical Care and Pain Management Department, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 14, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)