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临床试验/NCT04987866
NCT04987866已完成不适用

Vibration Anesthesia for Propofol- Rocuronium Injection Pain

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
preventing or reducing rocuronium injection pain

研究概览

简要总结

Despite numerous strategies for preventing or alleviating pain associated with propofol and rocuronium injections, it remains common and distressing for patients. Vibration is an effective method of reducing pain during facial cosmetic injections and some venipuncture procedures. But it has not been previously studied in the context of propofol or rocuronium injection pain. This randomized study aims to evaluate the effect of vibration anesthesia on the incidence and severity of propofol and rocuronium injection pain.

详细描述

Due to their rapid onset and short duration of action, ease of titration, recovery, and favorable profile for side effects, propofol and rocuronium are agents frequently used together in anesthesia practice and for rapid-sequence intubation. However, both cause severe discomfort due to pain in the injection arm. Some patients recall the induction of anesthesia as the most painful part of the perioperative period.

Vibration anesthesia has repeatedly been shown to alleviate pain sensation effectively and safely. Vibration anesthesia device is designed to reduce the pain from minor procedures, such as injection of medications, suture or staple removal, phlebotomy and even venipuncture pain in pediatric patients. The advantages of this device include its low cost, lack of adverse effects, and ease of use.

It has been shown to reduce pain with a mechanism based on the gate control theory, which states that vibrations stimulate the dorsal horn neurons, the sites at which pain signals are modulated and thus block full transmission of the pain.The investigators therefore proposed this randomized controlled study to compare the effectiveness of a vibration device for propofol and rocuronium injection pain during general anesthesia induction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA I-II patients
  • Patients who are planned to undergo gynecology operations

排除标准

  • Participants who were pregnant,
  • Patients who had a recent history of a severe allergic or hypersensitivity reaction to propofol or rocuronium

结局指标

主要结局

preventing or reducing rocuronium injection pain

时间窗: patients were observed during and after the injection of rocuronium for 20 seconds by an observer

The movement response to rocuronium injection pain was evaluated by the same observer on a four-point scale (FPS). The scale was 0: no movement, 1: movement only the wrist, 2: movement of only the arm (elbow-shoulder) and, 3: general response, movement more than one extremity. 2 minutes after induction, intubation was completed.

preventing or reducing propofol injection pain

时间窗: patients were observed during and after the injection of propofol for 20 seconds by an observer

Observer rated the pain responses according to a four-point scale. After the injection of propofol to, we also asked the patients whether they had any discomfort.The severity of propofol- injection was evaluated using the following four-point pain response scale developed by McCrirrick and Hunter: level 0: (no pain) no verbal/ facial/ motor reaction to the injection; level 1: (mild pain) a minor verbal/ facial/ motor reaction to the injection but no physical activity or wrist joint movements; and level 2: (moderate pain), pain when asked by the anesthesiologist, or complaint of pain during the injection accompanied by physical activity- facial grimacing or withdrawal of the arm (elbow-shoulder); and level 3: (sever pain), a response accompanied by a facial expression of pain, or a strong vocal response, tears, arm withdrawal, and full body reaction ( including other body movements)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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