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临床试验/CTRI/2018/05/013662
CTRI/2018/05/013662已完成不适用

Prediction of Hypotension after Spinal Anaesthesia by Inferior Vena Cava Collapsibility Index: an Observational Study

All India Institute Of Medical SciencesJodhpur1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
The incidence of hypotension after spinal anaesthesia in IVC compressible patients

研究概览

简要总结

Hypotension is commonly seen in patients where spinal anaesthesia is used for surgery, especially if the patient is hypovolaemic or fluid deficit. Ultrasound is currently being used in ICU for assessment of IVC diameter in patients with intravascular fluid deficit and in state of shock. We aim to measure the predicting value of inferior vena cava collapsibility index (IVC-CI) to correctly assess the intravascular volume status of patients belonging to American Society of Anesthesiologists (ASA) physical status grade I and II aged between 18 to 75 years undergoing surgery following spinal anaesthesia. Patients will be divided into two groups by calculating the IVC collapsibility index preoperatively as IVC compressible and IVC non compressible. Then intraoperative vitals will be monitored at fixed time interval following spinal anaesthesia using 0.25mg/kg 0.5% bupivacaine (heavy) and 25mcg fentanyl at L3-L4 level with 25/27 G spinal needle and significant hypotension (≤30% fall from baseline blood pressure) will be treated with fluids and vasopressors. At the end of the study, the occurrence and magnitude of hypotension in all these groups will be correlated with preoperative IVC-CI to assess its predicting value.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • patients belonging to American Society of Anaesthesiologists (ASA) physical status grade I and II, aged between 18 to 75 years, scheduled to undergo surgery in spinal anaesthesia will be enrolled.

排除标准

  • 1.Patient’s refusal to participate 2.Preexisting skin infection at spinal site 3.Any spinal deformity 4.History of previous spine surgery or fracture at block level 5.Coagulation Disorder 6.Presence of chest crepitations 7.Presence of congestive cardiac failure and fixed cardiac output diseases 8.Preoperative hypotension (Mean arterial blood pressure < 50 mmHg), preoperative bradycardia (Heart rate < 45 beats/min) and preoperative dysrhythmia.
  • 9.Preoperative uncontrolled hypertension (≥ 180/110) 10.History of psychiatric illness and preexisting neurological deficits 11.Patient with obesity BMI >30 kg /m2 12.Pregnant patients with gestational age more than 12 weeks 13.Known allergy to study drugs 14.Patient with WBC count more than 11000 15.History of previous diaphragmatic surgery 16.Intraabdominal compartment syndrome or Intraabdominal hypertension (increased Intraabdominal pressure >12 mm of Hg) 17.Congenital anomaly of inferior vena cava.

结局指标

主要结局

The incidence of hypotension after spinal anaesthesia in IVC compressible patients

时间窗: 30 minutes after spinal anaesthesia

次要结局

  • 1.The relation of duration and magnitude of hypotension with collapsibility index(2. Ease of visualisation of hepatic vein and IVC.)

研究者

发起方
All India Institute Of Medical SciencesJodhpur
申办方类型
Research institution and hospital

研究点 (1)

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