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临床试验/CTRI/2025/07/090681
CTRI/2025/07/090681尚未招募2 期

A comparitive study of fluid administration for prevention of spinal anaesthesia induced hypotension based IVC collapsibility index vs conventional method

ESIC Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
To study the occurrence of spinal anaesthesia induced hypotension in initial 30 minutes following the administration of spinal anaesthesia between IVC collapsibility Index based fluid administration group vs conventional method of fluid administration group

研究概览

简要总结

A Prospective Double Blinded Randomise Controlled Study which includes patients undergoing infraumblical surgeries. they are divided into two groups . An Ultrasound guided IVC diameter and IVC Collapsibility Index will be performed in supine position by an experienced anaesthetist will be done . In Group A patients IVC collapsibility index will be measured , those patients with IVC collapsibility index greater than or equal to 36 percent will be administered with 500 ml of fluids over 5 min after which IVC collapsibility index will be measured again . If the collapsibility index remains greater than or equal to 36 percent again 500 ml of fluid will be administered over 5 min and IVC  collapsibility index will be measured this procedure will be repeated until the collapsibility index becomes less than or equal to 36 percent. In group B patients , IVC collapsibility Index will be measured , a conventional method of fluid loading of 500ml will be administered irrespective of IVC collapsibility Index . Hemodynamic paramters including mean arterial pressure , systolic BP , diastolic BP , heart rate and requirement of vasopressors willl be recorded

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to ASA physical status I and II 18-60 years of age of both the sexes Patients undergoing infra umbilical surgeries with informed written consent.

排除标准

  • Patient refusal Patients having contraindications to spinal anaesthesia Known allergy to local anaesthetics coagulation disorders raised intracranial pressure infection at the site of injection.

结局指标

主要结局

To study the occurrence of spinal anaesthesia induced hypotension in initial 30 minutes following the administration of spinal anaesthesia between IVC collapsibility Index based fluid administration group vs conventional method of fluid administration group

时间窗: Every 3 min from 0 to 30 min after administration of spinal anaesthesia

次要结局

  • To calculate the average consumption of vasopressors INJ EPHIDREINE 5mg bolus & fluids RL between the two group(Every 3min from 0 to 30 min after administration of spinal anaesthesia)

研究者

发起方
ESIC Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Aparna V

ESIC Medical College and Hospital

研究点 (1)

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