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临床试验/CTRI/2025/10/095796
CTRI/2025/10/095796尚未招募不适用

Clinical utility of change in Carotid artery Corrected Flow time to predict hypotension after spinal anaesthesia in patients with diabetes mellitus.

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
To assess the predictive accuracy of Change in Common Carotid Corrected Flow Time for predicting post-spinal hypotension among diabetic patients undergoing elective surgeries.

研究概览

简要总结

The diabetic patient scheduled for elective surgery under spinal anaesthesia will be recruited following informed written consent. A thorough preoperative assessment will be done by the attending anaesthesiologist and history of duration of diabetes and current treatment will be obtained. Anthropometric assessment will be done. Routine investigations like RBS, HbA­1c, RFT, CXR and ECG will be reviewed. Premedication and diabetic medications will be prescribed as per department protocol.

 On the day of surgery, after arrival to the operating room, standard ASA monitors such as SpO2, NIBP, ECG will be attached. Ultrasound images of the Right Common Carotid artery in a long-axis view will be assessed using a 12-MHz linear-array probe by an experienced anaesthesiologist (more than 20 carotid scans). The measurement of the flow time would be performed first in supine position (FTc1) followed by 45 degreesleg end elevation (FTc2) with the help of a goniometer. The second reading will be taken after 1 min following leg elevation. The position of the measurement is around 3 cm proximal to the carotid bulb in the longitudinal plane. The cursor angle will be set parallel to the blood flow direction, and the angle of insonation will be set to less than 60 degrees. The Wodey’s formula will be used for the calculation of FTc.

After the FTc measurement, patients will be returned to the supine position. Preloading will be done with 10 ml/kg of Ringer Lactate. Spinal anaesthesia will be performed in the left lateral position using 0.5% hyperbaric bupivacaine 15mg (3mL) administered at L3-L4 level. The level of sensory block will be assessed with the help of Cold touch at 5-minute intervals and the highest level attained will be noted. Hemodynamic parameters will be recorded for 20 minutes from the administration of spinal anaesthesia. Hypotension is defined as fall in systolic blood pressure less than 90 mmHg, or reduction in Mean Arterial Pressure by 20% of the baseline value.

 If any hypotension develops, it would be treated with Inj. Mephenteramine 3 mg boluses. Total vasopressor use for each patient will be noted down. Fall in heart rate to less than 60 bpm will be considered as bradycardia and will be treated with Inj. Atropine 0.12 mg iv.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • Diabetic patients planned for elective surgery under spinal anaesthesia.

排除标准

  • Patients who are known cases of Carotid artery stenosis
  • Allergic to Local Anaesthetics
  • Patients taking Anti-Hypertensive drugs
  • Patients on Vaso-dilators
  • Patients having Peripheral Vascular Disease.

结局指标

主要结局

To assess the predictive accuracy of Change in Common Carotid Corrected Flow Time for predicting post-spinal hypotension among diabetic patients undergoing elective surgeries.

时间窗: every minute until 20 mins after admintistration of spinal anaesthesia

次要结局

  • To measure the usage of vasopressors in post spinal induced hypotension among diabetic patients(every minute until 20 mins after admintistration of spinal anaesthesia)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Alan S Moses

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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