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临床试验/CTRI/2024/11/076358
CTRI/2024/11/076358尚未招募3 期

Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia in elderly patients undergoing femur fracture surgery – A randomized double-blind study

Dr Arun Parthasarathy1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2024年11月18日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
118
试验地点
1
主要终点
To compare the hemodynamic stability between fractionated and bolus dose injection in spinal anaesthesia

研究概览

简要总结

The geriatric population, irrespective of the type of surgery they undergo, poses a challenge for the anaesthesiologists. This is attributed to the reduced functional reserve in the elderly, associated multiple comorbidities and frail nature. Elderly patients with femur fractures usually add to this challenge as they may present late to the hospital for their treatment, which increases the risk of perioperative adverse outcomes. Generally, spinal anaesthesia (SA) is commonly employed for lower limb surgeries. Its advantages are simple to perform, good analgesia, reduced blood loss and so on. But the sympatholysis produced by spinal anaesthesia when given as a bolus dose of local anaesthetics can lead to profound hypotension, which may not be tolerated by the elderly patients. This hypotension can predispose patients to have end organ damage, which contributes to the overall morbidity. Rate of injection is one of the factors determing the level of spinal block and incidence of hypotension. Fractionated dose of local anaesthetic in spinal anaesthesia is administering two-thirds of the total calculated dose initially following which the remaining one-third dose is given after a gap of 45 to 90 sec between the injections. This method has been shown to provide better hemodynamic stability and longer duration of analgesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
60.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • Elective femur fracture surgery, Age more than 60 years, ASA PS 1,2,3, Surgery planned under spinal anaesthesia.

排除标准

  • Patient refusal Absolute contraindications for spinal anaesthesia.

结局指标

主要结局

To compare the hemodynamic stability between fractionated and bolus dose injection in spinal anaesthesia

时间窗: Every 3 minutes for the initial 30 minutes

次要结局

  • To compare the time of onset and duration of sensory block(To compare the time of onset and duration of motor block)

研究者

发起方
Dr Arun Parthasarathy
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Arun Parthasarathy

Kasturba Medical College, Manipal

研究点 (1)

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