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临床试验/CTRI/2024/04/066498
CTRI/2024/04/066498尚未招募4 期

Evaluation of effectiveness of fluid management using ultrasound guided inferior vena cava collapsibility index in preventing spinal anaesthesia induced hypotension in urology surgeries - An open-label randomized controlled study

SRM medical college1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月16日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To assess the difference in incidence of spinal anaesthesia induced hypotension in group A and group B

研究概览

简要总结

A total of 100 patients belonging to age group 18 years to 65 years , ASA  1 and 2 undergoing urology surgeries will be studied,In this open-label randomized controlled trial a total of 100 patients will be divided into two groups Group A (preloading with 10ml/kg crystalloids) and Group B(optimising the fluid status by IVCCI preoperatively).Both the groups will undergo subarachnoid blockade using 2.5ml of Inj.Ropivacaine 0.75% using 25gauge quicke needle at L3-L4 vertebral space.If patients develop hypotension(defined as 20% drop in mean arterial pressure from baseline) 10ml/kg crystalloids will be administered initially followed by vasopressor ephedrine in 6mg bolus dose till mean arterial blood pressure increase to more than 70mmhg.Data collection will be done by measuring the volume of crystalloids, vasopressor ephedrine given and and difference in incidence of hypotension will be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • ASA 1 and 2 Urology surgery.

排除标准

  • Patients with coagulopathies Patients with neuropathies Patients with sepsis Uncompensated systemic disorders Transurethral resection of prostate Patients not consenting to spinal anesthesia.

结局指标

主要结局

To assess the difference in incidence of spinal anaesthesia induced hypotension in group A and group B

时间窗: 1min,5min,10min,15min,20min,25min,30min,40min,50min,60min,and every 15min till end of surgery

次要结局

  • To assess the volume of crystalloids transfused intraoperatively to manage spinal induced hypotension(End of surgery)
  • To assess the quantity of vasopressor ephedrine used intraoperatively to manage spinal induced hypotension(End of surgery)

研究者

发起方
SRM medical college
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Teepak Siddartha R

SRM Medical College hospital and Research centre

研究点 (1)

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