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临床试验/CTRI/2026/01/102625
CTRI/2026/01/102625尚未招募不适用

Correlation of subarachnoid space depth obtained from formula versus actual measurement at lumbar region to derive appropriate formula in patients undergoing spinal anaesthesia at a tertiary care centre- An observational study

Bangalore medical college and research institute1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月12日最近更新:
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
1. correlation between subarachanoid space depth estimation by derived formula and the actual measurement at lumbar region in patients (males, females and pregnant women) undergoing spinal anesthesia."

研究概览

简要总结

Subarachnoid block is a commonly practiced anaesthesia technique for lower abdominal and limb surgeries, including cesarean sections.Performed using an anatomical landmark guided, blind approach, its sucess depends on factors like height weight BMI and BSA.In conditions such as obesity, pregnancy or edema  estimating subaracnoid space depth is crucial to minimize failed attempts and complications. Existing predictive formulas, largely derived from western population, require validation in indians hence this study aims to establish a reliable, population-specific model for accurate SSD estimation.

A prospective observational study will be conducted at hospitals attached to BMCRI form febrauary 2026 to april 2026  to determine skin to subarachnoid space depth in indian adults undergoing spinal anaesthesia and to assess the accuracy of anthropometric data (height, weight,BMI,BSA) will be  collected and actual SSD will be  measured during midline lumbar puncture. Predicted SSDs will be  calculated using existing and newly derived equations to validate populaton- specific accuracy and improve procedural precision and safety.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • •ASA grade I/II patients posted for various elective surgeries under spinal anaesthesia in general, gynecology and obstetrics surgery unit.

排除标准

  • •1.Patients with known hypersensitivity/contraindication to study drugs.
  • •2.Patients with coagulation disorders, infection at the site of spinal injection.
  • •3.Patients with severe renal/hepatic/respiratory or cardiac disease.
  • •4.Pregnant patients with hypertensive disorders/in patients where paramedian approach of spinal anaesthesia will be used.
  • •5.Patients with neurological/psychiatric/neuromuscular disorders/spine anomaly.
  • •6.associated medical illness with relative contraindication to spinal anaesthesia.

结局指标

主要结局

1. correlation between subarachanoid space depth estimation by derived formula and the actual measurement at lumbar region in patients (males, females and pregnant women) undergoing spinal anesthesia."

时间窗: at baseline and immediate after giving spinal anaesthesia

2.validation of the formulas derived from the previous study by using sensitivity analysis in patients (males, females and pregnant women) undergoing spinal anesthesia.

时间窗: at baseline and immediate after giving spinal anaesthesia

次要结局

  • Derivation of appropriate formula for subarachanoid space depth calculation based on height, weight, BMI and BSA from the data obtained from this study.(within 1 minute of giving spinal anesthesia n)

研究者

发起方
Bangalore medical college and research institute
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR YATHISH S K

Bangalore medical college and research institute

研究点 (1)

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Finding the relation between existing formulas to... | 临床试验