Evaluation of Inferior Vena Cava and Femoral Vein Collapsibility Indices for Predicting Post-Spinal Hypotension in Patients Undergoing Transurethral Prostate Resection: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Prediction of Post-Spinal Hypotension Using Inferior Vena Cava and Femoral Vein Collapsibility Indices
研究概览
简要总结
Spinal anesthesia is commonly used in transurethral prostate resection (TUR-P) surgeries; however, post-spinal hypotension remains a frequent and clinically significant complication, particularly in elderly patients. Early prediction of hypotension may allow timely interventions and improve patient safety.
This prospective observational study aims to evaluate the predictive value of preoperative ultrasound-based inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for post-spinal hypotension in patients undergoing elective TUR-P under spinal anesthesia. Before spinal anesthesia, IVC and femoral vein measurements will be obtained using ultrasonography. Hemodynamic parameters will be recorded before and after spinal anesthesia, and the occurrence of hypotension will be assessed according to predefined criteria.
The study seeks to compare the diagnostic performance of IVC-CI and FVCI in predicting post-spinal hypotension and to identify potential clinical predictors associated with hypotension in this patient population.
详细描述
This study is designed as a prospective observational study conducted at the University of Health Sciences, Antalya Training and Research Hospital. The study will include adult patients scheduled for elective transurethral prostate resection (TUR-P) under spinal anesthesia.
Spinal anesthesia is frequently preferred in TUR-P procedures; however, post-spinal hypotension is a common complication, particularly in elderly patients and those with limited physiological reserve. Hypotension following spinal anesthesia is primarily caused by sympathetic blockade, leading to reduced vascular tone and venous return. Early identification of patients at risk for hypotension may enable timely preventive and therapeutic interventions and reduce perioperative morbidity.
Prior to spinal anesthesia, all eligible patients will undergo ultrasonographic assessment of the inferior vena cava (IVC) and femoral vein while in the supine position. Measurements will be performed using a convex ultrasound probe in M-mode. The maximum and minimum diameters of the IVC and femoral vein during the same respiratory cycle will be recorded, and the collapsibility indices will be calculated using standardized formulas.
No fluid preload will be administered before spinal anesthesia. Standard monitoring, including electrocardiography, oxygen saturation, and noninvasive or invasive blood pressure monitoring when clinically indicated, will be applied. Baseline heart rate and blood pressure values will be recorded immediately before spinal anesthesia. Following spinal anesthesia, hemodynamic parameters will be recorded at two-minute intervals for a total duration of 15 minutes.
Post-spinal hypotension will be defined as a systolic blood pressure less than 90 mmHg, a decrease in systolic blood pressure greater than 30% from baseline, or a mean arterial pressure below 60 mmHg. Patients will be categorized into hypotension and non-hypotension groups based on these criteria. Severe or prolonged hypotension episodes will be treated according to standard clinical practice.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-75 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective transurethral resection of the prostate (TUR-P)
- •Planned spinal anesthesia
- •Ability to provide written informed consent
排除标准
- •Refusal to participate in the study
- •Body mass index (BMI) >30 kg/m²
- •Use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers
- •Emergency surgery
- •Baseline systolic arterial blood pressure <90 mmHg or mean arterial pressure <70 mmHg
- •Major peripheral vascular disease or severe cardiovascular disease
- •Unstable angina or left ventricular ejection fraction <40%
- •Chronic respiratory disease
- •Increased intra-abdominal pressure
- •Autonomic nervous system disorders
- •Implanted pacemaker or implantable cardioverter-defibrillator
- •Anticipated difficult airway
- •Cognitive impairment or inability to cooperate
研究组 & 干预措施
Non-Hypotension Group
Patients who do not develop hypotension following spinal anesthesia.
Post-Spinal Hypotension Group
Patients who develop hypotension after spinal anesthesia according to predefined hemodynamic criteria.
结局指标
主要结局
Prediction of Post-Spinal Hypotension Using Inferior Vena Cava and Femoral Vein Collapsibility Indices
时间窗: Within the first 15 minutes after spinal anesthesia
The primary outcome is the predictive value of the inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for the development of post-spinal hypotension. Hypotension is defined as a systolic blood pressure \<90 mmHg, a decrease in systolic blood pressure \>30% from baseline, or a mean arterial pressure \<60 mmHg within 15 minutes after spinal anesthesia.
次要结局
- Comparison of Diagnostic Performance of IVC-CI and FVCI for Post-Spinal Hypotension(Within the first 15 minutes after spinal anesthesia)
研究者
Nilgun Kavrut Ozturk
Associate Professor of Anesthesiology and Reanimation
Antalya Training and Research Hospital