跳至主要内容
临床试验/CTRI/2024/07/071495
CTRI/2024/07/071495尚未招募不适用

A double blind study to assess the correlation of grade of lumbar puncture with bedside scoring system in patients scheduled for elective infra-umbilical surgeries under spinal anaesthesia at sms medical college, jaipur.

Sawai man singh medical college and hospitals1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2024年8月15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
157
试验地点
1
主要终点
Mean of Lumbar Puncture (LP) difficulty score based on 5 patient variables.

研究概览

简要总结

sample of 157 cases is calculated at 95% confidence level and 95% power to verify the expected proportion of 11% difficult lumbar puncture. After that two anaesthesiologists will be assigned for the study. During pre anaesthetic evaluation, patient will be assessed for 5 variables and each scored 0-3 as per proforma by one anaesthesiologist. Another anaesthesiologist with more than 5 years experience, who will not be involved in the pre-anaesthetic assessment of patient variables, will perform the lumbar puncture.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients scheduled for elective infra-umbilical surgery under spinal anaesthesia.
  • Patient giving written informed consent.
  • Age: between 20 to 70 years.
  • American Society of Anaesthesiologist (ASA) physical status I and II.

排除标准

  • Patient who is unable to perform forward bend test.
  • Pregnant women.

结局指标

主要结局

Mean of Lumbar Puncture (LP) difficulty score based on 5 patient variables.

时间窗: at baseline

次要结局

  • Mean of lumbar puncture grading (easy/ moderate/ difficult)(at 2mins after giving spinal anaesthesia)

研究者

发起方
Sawai man singh medical college and hospitals
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kanchan Chauhan

Sawai man singh medical college and hospitals

研究点 (1)

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