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临床试验/CTRI/2025/11/097290
CTRI/2025/11/097290尚未招募不适用

A study to evaluate the efficacy of USG guided inferior vena cava collapsibility index and caval aorta index in predicting the incidence of hypotension after spinal anaesthesia in S.M.S Medical College, Jaipur

Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
To assessment and compare the efficacy of inferior vena cava collapsibility index and caval aorta index in predicting hypotension after spinal anaesthesia.

研究概览

简要总结

Spinal anaesthesia-induced hypotension (SAIH) is a frequent side effect of spinal anaesthesia (SA), seen more commonly in hypovolemic patients which is due to sympathetic blockade and activation of cardioinhibitory fibres. Thus, fluid optimization becomes an important part in anaesthsia management. With the advent of Ultrasonography (USG), non invasive parameters such as inferior vena cava (IVC) diameters, IVC collapsibility index (IVCCI), caval aorta index (CAI) have shown promising results in terms of fluid optimization.  This study assesses and compares the efficacy of IVC collapsibility index (IVCCI) and caval aorta index (CAI) in predicting hypotension after spinal anaesthesia to allow timely and targeted intervention based on preoperative risk assessment.

Patients will be selected according to inclusion and exclusion criteria. Monitors will be attached and baseline vitals recorded. Ultrasound measurements will be performed in the preoperative room with the patient in the supine position. Measurements of the inferior vena cava (IVC) will be taken lateral to the IVC–hepatic vein junction. The internal anterior–posterior diameter, which is maximum during expiration (IVCmax)  and minimum during inspiration  (IVCmin) will be recorded. Maximum aortic diameter(Ao) on the left side of the IVC, 1 cm above the level of the celiac trunk, will be recorded during systole.

The IVC collapsibility index ( IVCCI ) will be calculated using the formula- ( (IVCmax-IVCmin) / IVCmax ) x 100

The caval aorta index will be calculated using the formula-  IVCmax / Ao

Spinal anesthesia will be administered under all aseptic precautions at the L3–L4 intervertebral level, with the patient in the sitting position, using 0.5% hyperbaric bupivacaine through a 25-gauge Quincke needle. Following the injection, the patient will be positioned supine. Infusion of Ringer lactate will be initiated only after the administration of spinal anaesthesia, at a rate of 10 mL/kg/hour. No preloading of fluid will be performed. Patients will be excluded from the study if the level of sensory block rises above the T5 dermatome.  Vital parameters will be recorded non-invasively at 0, 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, and 120 mins after spinal anesthesia.

If hypotension is observed, it will be managed with an intravenous bolus of 3 mg mephentermine. Any other complications, such as nausea or vomiting, will be managed appropriately.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective lower limb surgery under spinal anesthesia in supine position.
  • Patients giving informed written consent.
  • Patients with ASA Grade I,II.
  • Patients not a part of any other study.

排除标准

  • Pregnant patients.
  • Patients with Hypertension.
  • Patients with Increased intra-abdominal pressure.
  • Patient BMI more than 30kg/m2 Patients undergoing unilateral spinal anesthesia.

结局指标

主要结局

To assessment and compare the efficacy of inferior vena cava collapsibility index and caval aorta index in predicting hypotension after spinal anaesthesia.

时间窗: Monitoring vitals at 0,1,2,3,4,5,10,15,20,25,30,45,60,75,90,120 minutes following spinal anaesthesia

次要结局

  • To correlate relation of spinal anaesthesia induced hypotension with IVCmax diameter.
  • To correlate relation of spinal anaesthesia induced hypotension with IVCmin diameter.(Before giving spinal anaesthesia)
  • To correlate relation of spinal anaesthesia induced hypotension with maximum Aorta diameter.(Before giving spinal anaesthesia)
  • To correlate relation of spinal anaesthesia induced hypotension with pre operative mean arterial pressure.(Baseline before giving spinal anaesthesia)

研究者

发起方
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Chitra Singh

Sawai Man Singh Medical College

研究点 (1)

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