Vibration Analgesia in Propofol Infusion During Anesthesia Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Level of Pain as Observed by Two Independent Observers Following Propofol Injection, With or Without a Vibration Analgesia Adjunct
研究概览
简要总结
In this study, the investigators seek to evaluate the role of vibration in the reduction of discomfort associated with painful stimulus associated with anesthesia induction. Through this study, the investigators hope to develop a comprehensive and cost-effective approach to minimize patient discomfort during anesthesia induction.
详细描述
Background and Significance Infusion of propofol during the process of inducing anesthesia can cause a fair amount of transient discomfort to patients while the are on the operating table and of intact faculties. It is not uncommon for patients to cry out in pain. The investigators have noticed this first hand on numerous occasions and have wondered if there is a risk-free way to lesson the pain associated with propofol infusion.
This study will focus on the use of vibration analgesia to potentially reduce the pain associated with propofol infusion. Vibration is proposed to stimulate A-beta nerve fibers, which transmit information from vibration and touch which, according to the Gate Control Theory of Pain (Melzack and Wall 1965), inhibits signal transduction by A-delta and C fibers (Kakigi and Shibasaki 1992). Vibration has been demonstrated to be effective to decrease pain during vaccinations, phlebotomy, and dental anesthesia (Baxter et al. 2011; Nanitsos et al. 2009).
In this study, the investigators seek to evaluate the role of vibration in the reduction of discomfort associated with painful stimulus associated with anesthesia induction. Through this study, the investigators hope to develop a comprehensive and cost-effective approach to minimize patient discomfort during anesthesia induction.
Study Design
The objective of this study is to evaluate the effectiveness of vibration as a analgesic during induction of anesthesia. It is the investigators hypothesis that both vibration will lessen the pain of propofol infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those aged 18 to 100 who are going to receive propofol injection as part of induction of anesthesia for surgery
排除标准
- •Those below the age of 18
结局指标
主要结局
Level of Pain as Observed by Two Independent Observers Following Propofol Injection, With or Without a Vibration Analgesia Adjunct
时间窗: Day 1 at time of propofol injection
Patient pain will be assessed by two independent observers, an attending anesthesiologist and a certified registered nurse anesthetist (CRNA). Pain was graded using a four-point pain manifestation scale described by McCrirrick \& Hunter : 0 = none (negative response to questioning), 1 = mild (pain reported in response to questioning only, without any behavioral signs), 2 = moderate (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning), 3 = severe (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears). Higher scores meaning worse outcome (perceived pain) and lower score meaning better outcome.
次要结局
未报告次要终点
研究者
Aravind Pothula
Principal investigator
Montefiore Medical Center
