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临床试验/CTRI/2024/10/074558
CTRI/2024/10/074558尚未招募4 期

Determining Preload Volume using Point of Care Ultrasonography to Prevent Post Spinal Anaesthesia Hypotension- A Randomized Control Trail

Dr Balasubramaniam C1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年10月9日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
56
试验地点
1
主要终点
Primary objective of the study will be to assess the episodes of hypotension (hypotension defined as MAP ≤80% of the baseline or MAP ≤60mmhg)

研究概览

简要总结

Intraoperative hypotension, a recognized risk factor for perioperative morbidity and mortality, is a notable concern in clinical practice. While spinal anesthesia is a frequently employed technique known for its capacity to mitigate the surgical stress response, enhance postoperative oxygenation, and reduce the incidence of postoperative pulmonary complications and deep vein thrombosis, it is, however, also associated with a significant drawback: the propensity to induce hypotension.

Various preventive measures are recommended to address this hypotension, including the use of vasopressor medications, administering fluids, and positioning the patient on their left side. Overly aggressive treatment with vasopressors and fluids can lead to other circulatory complications like hypertension, bradycardia, tachycardia, arrhythmia, and even pulmonary edema.

Transthoracic echocardiography (TTE) is commonly employed in the operating room for real-time assessment of patients with unstable hemodynamic and to predict fluid responsiveness. For spontaneously breathing patients, changes in the velocity-time integral (VTI) of the left ventricular outflow tract induced by a passive leg raise (PLR) is an innovative tool and can accurately predict fluid responsiveness.

In our study we focus on preloading, to address the challenge of optimal fluid administration, point of care ultrasound is used to detect cardiac parameters.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 18 to 60 years of age ASA Grade I and II Surgery not lasting for more than 3 hours.

排除标准

  • Emergency Surgeries Under general anesthesia Neurologic disorders Cardiac Anomalies.

结局指标

主要结局

Primary objective of the study will be to assess the episodes of hypotension (hypotension defined as MAP ≤80% of the baseline or MAP ≤60mmhg)

时间窗: It will be assessed every 5 minutes after giving spinal anaesthesia for the first 40 minutes

次要结局

  • Secondary objective will be calculating the amount of vasopressor used and total intraoperative fluid given(At the end of first hour of surgery)

研究者

发起方
Dr Balasubramaniam C
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Balasubramaniam C

J N Medical College, Belagavi

研究点 (1)

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