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临床试验/CTRI/2025/10/096135
CTRI/2025/10/096135尚未招募不适用

Comparison Of Pre-Operative Ultrasonographic Evaluation Of Caval-Aorta Index With Subclavian Vein Collapsibility Index For Prediction Of Hypotension During Induction Of General Anesthesia In Adult Patient

未提供1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2025年10月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
97
试验地点
1
主要终点
4. Mean arterial blood pressure

研究概览

简要总结

Pre-Operative Measurement of Indices

The patient will be wheeled into the pre operative area, and the procedures will be explained  to the patient and informed written consent will be obtained in a language that is understood  by the patient. Following this, the diameters of the Inferior Vena Cava, Abdominal Aorta,  Subclavian vein will be measured in supine position, as described below

 To  measure Caval Aorta index

The IVC diameter will be measured using a curvilinear probe of 2 to 5MHz of the USG  machine. The probe will be placed in the subxiphoid region where the confluence of the  hepatic veins can be visualized that drain into the IVC in the B mode. 1cm caudal to the confluence of the  hepatic veins and IVC, the greatest internal anterior posterior diameter of the IVC in the  longitudinal plane will be measured, in the M mode. In the subxiphoid region, lying left  lateral to the IVC, will be the Aorta; the maximum internal AP diameter of the Abdominal  Aorta will be measured in the longitudinal plane, on the M mode 10 mm above the coeliac trunk.

 Ultrasound guided Subclavian Vein Measurements

Ultrasonographic measurements will be performed before induction of general anesthesia . All patients will lie at supine position  and breathing spontaneously for at least 5 min before assessment. Right SCV diameters will be measured in the supine position using ultrasonography device and a high-frequency linear probe 6 to 14MHz. The short axis image of the SCV will be obtained by placing the probe just below the clavicle and scanning it from the midline laterally.

The patient in the supine position will be asked to do a normal inspiration and then a deep inspiration which is as deeply as possible and exhale naturally, and the minimum diameter and maximum diameter of the SCV will be measured in the M mode of ultrasound at a medium sweep speed during both normal and deep inspiration.

The mean of three measurements will be selected.

  Anesthetic Procedure

In the operation theatre, ASA standard monitors will be attached to the patient. The values of  Heart rate , systolic blood pressure , diastolic blood pressure  and mean  blood pressure, obtained in supine position before any intervention or drug  administration will be considered as Baseline Values. A 18G peripheral intravenous cannula  will be secured, and Ringer Lactate infusion will be started 10ml per kg per hr. Following drugs  will be administered for induction of general anesthesia.  Premedication with Inj. Midazolam  1mg i.v. stat, Inj. Fentanyl 2mcg per kg for analgesia Induction with Inj. Propofol 2mg per kg  for induction inhalational agent used will be Sevoflurane 2 to 4 percent to achieve a MAC of 1.0, &  Inj. Vecuronium 0.1mg per kg for muscle relaxation. For the next five minutes, the  hemodynamic parameters, i.e., HR, SBP, DBP, & MAP, will be measured every minute.  During these five minutes, the patient will be ventilated by volume-controlled mode with the  following ventilation setting: Tidal volume 6 to 8ml per kg, Frequency 12 per min, PEEP 0 cm of

H  2 O, Inspiratory and expiratory ratio of 1 and 2. After the fifth minute, the        patient will be intubated to secure the airway.  Hypotension will be defined as a fall of SBP by more than 20 percent at any point of time, and it will be  treated by giving IV fluid, and or Inj. Mephentermine 3 to 6 mg i.v. bolus.

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

  • Adult patients (more than 18 years)
  • American Society of Anesthesiology Physical Status 1 & 2.

排除标准

  • 1.Patient with Cardiovascular diseases (Heart failure, Valvular heart diseases, MI, Aortic diseases, Peripheral vascular diseases) 2.Portal hypertension 3.Pregnant Female 4.Patients with neck surgeries.

结局指标

主要结局

4. Mean arterial blood pressure

时间窗: at baseline

Hemodynamic parameters

时间窗: at baseline

1. Heart rate

时间窗: at baseline

2. Systolic blood Pressure.

时间窗: at baseline

3. Diastolic blood pressure.

时间窗: at baseline

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Jasmin

ABVIMS and Dr Ram Manohar Lohia Hospital, New Delhi

研究点 (1)

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