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临床试验/CTRI/2025/04/083773
CTRI/2025/04/083773尚未招募不适用

Efficacy of Inferior Vena Cava Collapsibility Index, Internal Jugular Vein Collapsibility Index and Caval Aorta Index in predicting the incidence of hypotension after spinal anaesthesia

Dr Aleena Treasa Rodrigues1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2025年4月8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
85
试验地点
1
主要终点
To compare the sensitivity of IVC collapsibility index, IJV collapsibility index and aorta caval index in predicting spinal anaesthesia induced hypotension in adults undergoing surgery in supine position

研究概览

简要总结

After obtaining approval from Institutional Ethics Committee and written informed consent from the participants, patients will be recruited in accordance with the predefined inclusion and exclusion criteria.

These pre – operative parameters will be recorded

1.     Age

2.     Gender

3.     Weight

4.     Height

5.     BMI

6.     ASA grade

7.     Baseline BP and MAP

8.     Baseline HR

9.     Baseline oxygen saturation

All patients will be fasting as per standard protocol (6 hrs for solids and 2 hrs for clear liquids). On the day of surgery, USG measurement of IVC, IJV and aorta diameters will be done in the preoperative holding area by a trained operator, with the patients in supine position. A phased array probe of a standard USG machine will be used for the study.

Inferior Venacava Measurement:

With the transducer kept in the subxiphoid region, IVC measurements will be taken lateral to the IVC - hepatic vein junction. In one respiratory cycle IVC AP diameter during expiration (IVCmax) and inspiration (IVCmin) will be measured.

Aorta Measurement:

The transducer will be kept in the subxiphoid region. Aorta will be identified and maximum aorta internal diameter at systole will be measured.

Internal Jugular Vein Measurement:

The transducer will be kept lateral to the middle level of thyroid cartilage and a clear transverse view of the IJV will be obtained. In one respiratory cycle, IJV diameter during expiration (IJVmax) and inspiration (IJVmin) will be measured.

Procedure for spinal anaesthesia:

Intraoperatively, non-invasive blood pressure (NIBP) to measure the systolic, diastolic blood pressures and mean arterial pressure, heart rate, 5 lead ECG and oxygen saturation will be monitored. Availability of IV access with appropriate gauge IV canula in a peripheral line will be ensured. After the administration of spinal anaesthesia, intraoperative infusion of crystalloid solution at the rate of 10ml/kg/hr will be started.

Sub arachnoid block (SAB) will be administered to the patient positioned as sitting, with 25G Quincke – Babcock needle, at the L3-L4 or L4-L5 intervertebral space, and 3ml, 0.5% Hyperbaric Bupivacaine will be instilled in the space. Patient will be kept supine after SAB throughout the study period (30 mins). After recruitment, if level of anaesthesia achieved is above T5, then that patient will be excluded from the analysis.

NIBP, HR and SpO2 will be recorded every 2 minutes for the first 10 minutes and every 5 minutes until 30 mins after SAB. Post spinal anaesthesia hypotension is defined as fall in SBP by more than 20% of baseline OR absolute value of SBP < 90 mm Hg OR MAP less than 60 mm Hg. Any episode of hypotension will be noted and managed with 6 mg IV Mephentermine or Ephedrine to keep BP within 20% of baseline. Complications like bradycardia, nausea or vomiting will also be noted and managed accordingly.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of either gender of the age group eighteen to fifty nine years
  • Consenting to the study
  • Belonging to American Society of Anaesthesiologists physical status one or two
  • Undergoing elective surgery under spinal anaesthesia.
  • The patient has to be in supine position for the entire duration of surgery.

排除标准

  • Patients with hypertension
  • Patients with LVEF less than forty percent
  • Patients with increased intraabdominal pressure
  • Patients with BMI greater than thirty kilogram per meter square
  • Surgeries done under unilateral spinal anaesthesia
  • Pregnant patients
  • Failure to perform spinal anaesthesia.
  • After recruitment, if level of anaesthesia achieved is above thoracic level five.

结局指标

主要结局

To compare the sensitivity of IVC collapsibility index, IJV collapsibility index and aorta caval index in predicting spinal anaesthesia induced hypotension in adults undergoing surgery in supine position

时间窗: Baseline vitals are noted along with measurement of IVC, IJV and aorta diameter. NIBP, HR and SpO2 will be recorded every 2 minutes for the first 10 minutes and every 5 minutes until 30 mins after spinal anaesthesia. Outcome would be presence of hypotension post spinal anaesthesia, and that will be measured intraoperatively.

次要结局

  • To associate other baseline patient specific parameters with spinal anaesthesia induced hypotension(Baseline vitals are noted along with measurement of IVC, IJV & aorta diameter. NIBP, HR & SpO2 will be recorded every 2 minutes for the first 10 minutes & every 5 minutes until 30 mins after spinal anaesthesia. Outcome would be presence of hypotension post spinal anaesthesia, & that will be measured intraoperatively.)

研究者

发起方
Dr Aleena Treasa Rodrigues
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Aleena Treasa Rodrigues

St Johns Medical College Hospital

研究点 (1)

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