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临床试验/CTRI/2024/07/071737
CTRI/2024/07/071737尚未招募不适用

Role of ultrasonographic Inferior Vena Cava collapsibility index in predicting spinal anaesthesia induced hypotension in elective lower abdominal surgeries.

GCS Medical College Hospital and Research centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Ultrasonographic inferior vena cava collapsibility index more 35 will predict spinal anaesthesia induced hypotension

研究概览

简要总结

Written informed consent will be taken. Patients will be kept nil by mouth as per standard protocol. In the operating theatre, 18G cannula will be secured in a peripheral vein, standard monitoring will be applied and baseline HR, SBP, DBP, MAP & SpO2 will be recorded before administering SA in supine position.

Ultrasound guided IVC diameter measurements will be done by an experienced anaesthetist using a curvilinear probe of 1-8 MHz during spontaneous breathing through subxiphoid view lateral to the IVC-hepatic vein junction. IVC anterioposterior diameter which is maximum during expiration (IVCmax) and minimum during inspiration (IVCmin) will be taken in one respiratory cycle using M-mode of ultrasound. IVCCI will be calculated using the formula: [{IVCmax-IVCmin}/IVCmax]*100.

No fluid preloading will be done and the infusion of Ringer’s Lactate solution at a rate of 10ml/kg/hr will be started only after administration of SA in a sitting position at L3-L4 intervertebral space with a dose of 3.5 ml of 0.5% hyperbaric bupivacaine through 25G spinal needle to achieve spinal blockade of T8.

Patients will be kept supine after SA and the pin prick test will be used to evaluate the level of sensory blockade. HR, SBP, DBP, MAP and SpO2 will be recorded every 2 minutes for 10 minutes and every 5 minutes for 30 minutes after the administration of SA.

SAIH (spinal anaesthesia induced hypotension) will be defined as a decrease in SBP by more than 20% of the baseline value or MAP <60 mmHg.

Any episode of hypotension will be noted and managed with 6mg i.v. mephentermine to keep BP within 20% of baseline. Any complications like bradycardia, nausea or vomiting will be noted and managed accordingly

All the factors known to affect SAIH i.e. age, gender, height, weight, BMI, IVCCI will be included in the final multivariate model for finding the single most useful SAIH predicting variable..

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients who have given written informed consent posted for elective lower abdominal surgeries under spinal anaesthesia requiring spinal level T6-T8 under supine position, ASA grade I and II and BMI less than 30 kg/m2 will be included in our study.

排除标准

  • ASA III and IV Pregnant patients Patients with baseline BP less than 90mmHg Raised intra-abdominal pressure BMI more than 30kg/m2 Patients undergoing unilateral spinal anaesthesia Patients with known allergy to local anaesthetics.

结局指标

主要结局

Ultrasonographic inferior vena cava collapsibility index more 35 will predict spinal anaesthesia induced hypotension

时间窗: 8 weeks

次要结局

  • Non-invasive predictor for spinal anaesthesia induced hypotension(8 weeks)

研究者

发起方
GCS Medical College Hospital and Research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Disha Shah

Anaesthesiology department

研究点 (1)

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