跳至主要内容
临床试验/CTRI/2022/04/041964
CTRI/2022/04/041964已完成不适用

A study to compare ultrasound aided and landmark guided paramedian spinal anaesthesia in elderly patients.

Dept of Anaesthesiology Pt B D Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月25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
60
试验地点
1
主要终点
To compare the two groups with regards to the number of needle passes (the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin.)

研究概览

简要总结

The present study will be conducted in the Department ofAnaesthesiology and Critical care, Pt B. D. Sharma, PGIMS, Rohtak, in 60patients of either sex aged â‰¥60 years (ASA I,II,III) posted for surgeryunder spinal anaesthesia.  The aim of thestudy is to compare preprocedural ultrasound aided and landmark guidedparamedian spinal anaesthesia in elderly patients. In ultrasound aided group, a preprocedural ultrasound scan will be performed and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. In landmark guided group spinal anesthesia will be performed using conventional landmark-guided paramedian technique. The primary objective of thestudy is to compare the two groups with regards to number of needle passes (thenumber of forward advancements of the spinal needle in a given interspinousspace, i.e., withdrawal and redirection of spinal needle without exiting theskin). The secondary objectives are to compare the two groups with regard to number of skin insertion attempts,time for identifying landmarks,time for administering spinal anaesthesia and assessment of periprocedural discomfort.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Elderly patients (age≥60 years) scheduled to undergoing surgery under spinal anesthesia.
  • Patients with ASA physical status classification I, II, III.

排除标准

  • Patients having contraindication to spinal anaesthesia (coagulopathy, local infection, allergy to local anesthetic).
  • Patients having marked spinal deformity and history of previous spinal surgery.
  • Patients having BMI≥
  • Patients unwilling to participate.

结局指标

主要结局

To compare the two groups with regards to the number of needle passes (the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin.)

时间窗: 1. Initiation of spinal anesthesia. | 2. Completion of spinal anesthetic injection.

次要结局

  • Number of skin insertion attempts (the number of times the spinal needle was withdrawn from the skin and reinserted)(1. Initiation of spinal anesthesia.)
  • Time for identifying landmarks.(1. Initiation of spinal anesthesia)
  • Time for administering spinal anaesthesia.(1. Initiation of spinal anesthesia)
  • Assessment of periprocedural discomfort.(1. Initiation of spinal anesthesia.)

研究者

发起方
Dept of Anaesthesiology Pt B D Sharma PGIMS Rohtak
申办方类型
Government medical college

研究点 (1)

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