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临床试验/NCT07333703
NCT07333703已完成不适用

MRI-Based Estimation of Lumbar CSF Volume and Its Clinical Impact on Spinal Anaesthesia

Samsun University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
The primary outcome was to assess the correlation between lumbosacral CSF volume and peak sensory block level.

研究概览

简要总结

This prospective observational study aims to investigate the clinical impact of lumbar cerebrospinal fluid (CSF) volume on spinal anesthesia characteristics. A total of 40 adult patients, aged 18 to 75 years and classified as ASA physical status I-III, who had undergone 3D T2-weighted lumbosacral MRI within the past six months, were enrolled. Intrathecal anesthesia was administered with 4 mL (20 mg) of 0.5% hyperbaric bupivacaine via the L3-L4 interspace in a sitting position.

CSF volume was measured from the lower half of the L1 vertebral body to the sacral end using the volume of interest (VOI) method on sagittal 3D T2-weighted MR images, processed with the ITK-SNAP software. Primary outcome was the correlation between lumbosacral CSF volume and peak sensory block level. Secondary outcomes included correlations with the onset time and duration of sensory and motor block, two-segment regression time, and patient characteristics such as height, weight, BMI, and age.

详细描述

Spinal anesthesia is a widely used and effective alternative to general anesthesia for surgeries performed below the L₁-L₂ level, where the spinal cord ends. However, the distribution and duration of local anesthetics in spinal anesthesia are often unpredictable due to factors such as anesthetic dose, injection speed and location, patient position, age, and body habitus. One important yet less predictable factor is the individual variability in cerebrospinal fluid (CSF) volume, especially in the lumbosacral region. Since CSF dilutes the intrathecally administered anesthetic, differences in CSF volume can significantly impact drug concentration and, consequently, block level and duration.

Advancements in imaging techniques such as ultrasound and MRI have contributed to more accurate estimations of CSF volume. While most studies have used ultrasound-based estimations, MRI-based evaluations remain limited. In this study, we aimed to investigate the effect of lumbosacral CSF volume, measured via 3D T₂-weighted MRI, on the duration and extent of spinal anesthesia. Understanding this relationship could improve predictability in spinal anesthesia and enhance personalized anesthetic planning.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-75 years
  • ASA physical status I-III
  • Who had undergone 1.5 Tesla lumbosacral MRI within the last six months

排除标准

  • The presence of neurological diseases and allergy to local anesthetics
  • Refusal to undergo spinal anesthesia
  • Contraindications for spinal anesthesia
  • Local infection at the lumbar site

结局指标

主要结局

The primary outcome was to assess the correlation between lumbosacral CSF volume and peak sensory block level.

时间窗: From enrollment to the end of study 33 months

次要结局

未报告次要终点

研究者

发起方
Samsun University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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