Inferior Vena Cava Collapsibility Index Guided Fluid Management Versus Conventional Fluid Management in Prevention of Spinal Anaesthesia Induced Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare spinal anaesthesia induced hypotension in IVCCI guided Fluid management and Standard Fluid Management.
研究概览
简要总结
INTRODUCTION: Spinal anaesthesia (SA) is effective for surgeries involving the lower body, but often causes hypotension and bradycardia due to sympathetic denervation and peripheral vasodilation. Hypotension, linked to adverse outcomes, is more common in hypovolemic patients. Traditional fluid and vasopressor prophylaxis have mixed results and potential side effects. Non-invasive ultrasound, particularly the IVC collapsibility index (IVC CI), shows promise in predicting and managing spinal-induced hypotension, prompting our study to evaluate IVC CI-guided fluid management in this context.
AIM: To compare the efficacy of Inferior Vena Cava Collapsibility Index guided Fluid Management and Standard Fluid Management on Spinal Anaesthesia induced Hypotension in terms of Incidence of hypotension, total amount of fluid administered and incidence of use of vasopressor drugs in patients undergoing elective surgeries.
OBJECTIVES: To access and compare the efficacy of IVCCI guided fluid management and Standard fluid management in prevention of Spinal induced Hypotension and to calculate the total volume of fluid administered and incidence of use of vasopressors.
METHODOLOGY: A randomized, controlled, interventional study will be conducted in 100 patients (aged 18-65) undergoing elective surgeries under spinal anaesthesia. Patients will be randomly allocated into 2 groups of 50 each – Group A receiving IVCCI guided fluid management and Group B receiving Standard fluid management. Incidence of spinal anaesthesia induced hypotension along with total amount of fluid administered and incidence of use of vasopressor drugs during the surgery will be noted in these patients. SIGNIFICANCE OF THE STUDY: Spinal anaesthesia induced hypotension is a prevalent hemodynamic complications and cardiovascular side effect. The Inferior Vena Cava Collapsibility Index (IVC-CI) offers a non-invasive, real-time evaluation of fluid status for fluid management. This study investigates the efficacy of IVC-CI guided fluid management in comparison to standard fluid management in preventing spinal anaesthesia-induced hypotension, potentially enhancing patient outcomes and care efficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Having ASA Grade-I and II 2.Non Cardiovascular, non obstetric surgery under Spinal Anaesthesia.
排除标准
- •1.Contraindications to Spinal Anaesthesia
- •pre-existing hypotension
- •Severe cardiovascular diseases.
- •unstable angina, implanted pacemaker, decompensated heart failure, elevated pulmonary artery pressure
- •pregnant patients
- •Low Ejection Fraction
- •BMI more than 30kg per m2.
结局指标
主要结局
To compare spinal anaesthesia induced hypotension in IVCCI guided Fluid management and Standard Fluid Management.
时间窗: outcome will be assessed using blood pressure as a measure(every 10 min) till the effect of spinal anaesthesia wears off. The end point will be the two segment regression of sensory effect under spinal anaesthesia, which will be approximately 2-4 hours.
次要结局
- 1. Amount of fluid given to prevent spinal induced hypotension(2. Incidence of use of vasopressor drugs to prevent spinal induced hypotension)
研究者
Dr Ruchi Gupta
Sri Guru Ram Das Institute of Medical Sciences and Research