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临床试验/NCT05924230
NCT05924230招募中不适用

Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension Predicted by Inferior Vena Cava Collapsibility Index in Patients Receiving General Anesthesia

Tata Main Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Effective dose of Ringer's lactate solution to prevent post-induction hypotension

研究概览

简要总结

To assess the dose responsiveness of ringer lactate solution in prevention of post-induction hypotension predicted by Ultrasound guided Inferior Vena Cava diameter in patients receiving General anesthesia.

OBJECTIVES Primary - To find the optimum preloading dosage of Ringer Lactate to prevent post induction hypotension.

Secondary - To find the predictive incidence of Post-induction hypotension according to age, gender, type of surgery and comorbidities.

详细描述

All patients, after Ultrasonographic Inferior vena cava collapsibility index calculation, will receive Lactated Ringer's solution as per body weight and as per their allocated group in the receiving area.

After induction inside the Operating Room, All patients will be monitored continuously using Electrocardiography, pulse oximetry, noninvasive Blood pressure measurement and capnography .

Heart rate, Systolic - Diastolic - Mean blood pressure, Oxygen saturation will be monitored as follows :

  1. Baseline parameters - Prior to administration of intravenous Ringer's lactate solution
  2. T0 (after administration of intravenous Ringer's lactate solution but prior to induction of anaesthesia),
  3. T1-T10 (every minute for first 10 mins after induction of anaesthesia) Our institutional standard practice of induction of Anaesthesia with Fentanyl (2 μg/kg), Propofol (2 mg/kg) and Vecuronium (0.1mg/kg ) will be followed and intubation will be done only after first 10 mins post induction.

Amount of Mephentermine needed to correct hypotension despite RL infusion will also be calculated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age ≥ 18 years American Society of Anesthesiologists (ASA) Physical status classification system group I and II Elective surgery under General anesthesia

排除标准

  • •Age <18 and > 65 American Society of Anesthesiologists (ASA) Physical status classification system group III and IV Systolic blood pressure ≥ 180 mmHg Systolic blood pressure < 90 mmHg Pregnant women Patients with abdominal mass or ascites Emergency surgery

研究组 & 干预措施

RL 10

Active Comparator

Patients of this group will receive Ringer's lactate (RL) 10ml/kg

干预措施: RL 10ml/kg (Other)

RL 15

Active Comparator

Patients of this group will receive 15ml/kg of Ringer's lactate solution

干预措施: RL 15ml/kg (Other)

结局指标

主要结局

Effective dose of Ringer's lactate solution to prevent post-induction hypotension

时间窗: 15 months

This study will try to find out the effective dose of Ringer's lactate solution in ml/Kg that will prevent hypotension after induction of anaesthesia in study population

次要结局

  • Effect of age, gender, types of surgery and comorbid conditions on post-induction hypotension(15 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abhishek Chatterjee

Consultant

Tata Main Hospital

研究点 (1)

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