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临床试验/CTRI/2024/08/072563
CTRI/2024/08/072563尚未招募2 期

Prediction of post spinal anesthesia hypotension by femoral vein - femoral artery diameter ratio vs inferior vena cava - aorta diameter ratio.

Dayanand medical college and hospital1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年8月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
The primary outcome will be measured as sensitivity and specificity of femoral vein – femoral artery diameter ratio and inferior vena cava – aorta diameter ratio in predicting hypotension in patients aged 50 years and above.

研究概览

简要总结

Post spinal anaesthesia hypotension (PSAH) is seen in 15.3 to 33% of patients. In elderly (aged above 50 years), increased resting sympathetic tone and age related alteration in systolic function and diastolic relaxation might exacerbate the decline in cardiac output, increasing the risk of PSAH in these patients. The degree of hypotension and bradycardia induced by spinal anesthesia (SA) is determined by pre operative volume status. Therefore, there is need for assessing pre operative volume status and timely intervention accordingly. Both invasive and non-invasive methods have been explored. Invasive methods include measuring central venous pressure and mean pulmonary artery pressure. Non-invasive approaches involve ultrasonographic measurements of inferior vena cava (IVC), aorta diameter, IVC collapsibility index. This observational, prospective, double blind study will be conducted on a total of 105 patients of either sex, aged 50 years and above, belonging to ASA (American Society of Anesthesiologists) grade I, II & III scheduled for elective surgery under SA. Before giving SA, transverse diameters of femoral vein and femoral artery and anteroposterior diameters of IVC and aorta will be measured using ultrasound. A 2 ml (10 mg) of 0.5% bupivacaine HCl (heavy) and 0.5 ml fentanyl citrate (25 mcg), [total drug volume- 2.5 ml] will be given into subarachnoid space at the level of L3-L4 or L4-L5 intervertebral space in sitting position. After administration of SA, vitals including heart rate, systolic blood pressure(SBP), diastolic blood pressure, mean arterial pressure, respiratory rate, oxygen saturation will be monitored every 2 minutes till 30 minutes. The primary outcome will be measured as the sensitivity and specificity of femoral vein – femoral artery diameter ratio and inferior vena cava – aorta diameter ratio in predicting hypotension in patients aged 50 years and above. The secondary outcome will be measured as correlation between vessel diameter ratios and severity of hypotension episodes and the potential clinical implications of using vessel diameter ratios as predictors of post spinal anesthesia hypotension, including their role in risk stratification.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant and Investigator Blinded

入排标准

年龄范围
50.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Age greater than 50 years 2.Either gender 3.American Society of Anesthesiologists’ (ASA) physical status I, II or III 4.Scheduled for elective surgery under spinal anesthesia.

排除标准

  • 1.Body Mass Index (BMI) exceeding 30 kg/m² 2.Taking angiotensin-converting enzyme inhibitors 3.Presence of any contraindications to spinal anesthesia 4.Patients scheduled specifically for unilateral spinal anesthesia 5.Failed spinal anesthesia 6.Patients with a baseline arterial systolic blood pressure (SBP) lower than 90 mmHg 7.Patient refusal to participate in study.

结局指标

主要结局

The primary outcome will be measured as sensitivity and specificity of femoral vein – femoral artery diameter ratio and inferior vena cava – aorta diameter ratio in predicting hypotension in patients aged 50 years and above.

时间窗: The vitals of patients will be observed every 2 minutes till 30 minutes after spinal anaesthesia administration

次要结局

  • The secondary outcome will be measured as correlation between vessel diameter ratios and severity of hypotension episodes and to explore the potential clinical implications of using vessel diameter ratios as predictors of post spinal anesthesia hypotension, including their role in risk stratification.

研究者

发起方
Dayanand medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Suneet Kant Kathuria

Dayanand Medical College and Hospital

研究点 (1)

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