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临床试验/CTRI/2019/12/022468
CTRI/2019/12/022468尚未招募不适用

A comparative study on the effect of carrier fluid and propofol temperature on reducing propofol injection pain

MS Ramaiah Medical College and hospitals1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2019年12月20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
144
试验地点
1
主要终点
To assess the incidence and degree of pain during Propofol injection using warm or cold propofol with heated or cold carrier fluid.

研究概览

简要总结

Propofol is the most commonly used rapidly acting intravenous agent forinduction of general anesthesia. However, pain during induction remains acommon problem, with many patients complaining pain was intense. Some patientseven reported to be having stated that the pain was most unbearable experienceduring the perioperative period. Pain may also reduce patientsatisfaction with anaesthesia. Different methods have been used to reduce this discomfort including,topical cooling with addition of lignocaine, combination of nitroglycerine and lignocaine with venous occlusion, local  warming and local  cooling, intravenous lignocaine injection priorto propofol injection and warming propofol to 37°C. Propofolinjection pain still remains a major problem because its complete eliminationis challenging. There are no studies on effect of warming of propofol and carrier fluidsto alleviate the pain on propofol injection. This paucity of literature in acommon clinical scenario has necessitated taking up this clinical study andthereby contributing to literature in this subject area under study. This study aims to determine the incidence of pain on injection ofpropofol and the degree of pain alleviation with propofol and carrier fluid atdifferent temperature.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • patients undergoing elective surgeries under general anaesthesia.

排除标准

  • Allergy to propofol Inability to comprehend Verbal Rating Scale (VRS) Pregnant and breastfeeding women Peripheral neuropathy Patients with skin disease or erythema.

结局指标

主要结局

To assess the incidence and degree of pain during Propofol injection using warm or cold propofol with heated or cold carrier fluid.

时间窗: immediately after intervention

次要结局

  • To observe hemodynamic changes during propofol injection at different temperatures.(baseline, pre-induction, immediately after intervention, every minute for three minutes)

研究者

发起方
MS Ramaiah Medical College and hospitals
申办方类型
Private medical college

研究点 (1)

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