Evaluation of Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Spinal Anesthesia: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Predictive ability of the transverse diameter of the right common femoral vein (RCFV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Study group
Patients undergoing elective lower-limb orthopedic surgery under spinal anesthesia
干预措施: Measurement of Femoral Vein Diameter (Other)
结局指标
主要结局
Predictive ability of the transverse diameter of the right common femoral vein (RCFV)
时间窗: 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.
次要结局
- Severity of post spinal hypotension(24 hours postoperatively)
- Incidence of adverse events(24 hours postoperatively)
- Requirement of rescue medications(24 hours postoperatively)
研究者
Hebatallah Salah Abdelhamid
Lecturer of Anesthesia, Surgical Critical Care and Pain Management Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Cairo University