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临床试验/NCT05046054
NCT05046054Unknown不适用

The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection

Kyungpook National University Hospital2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
pain during propofol injection

研究概览

简要总结

Propofol, an intravenous sedative agent, frequently produces pain during injection. This study was designed to investigate whether transcutaneous electrical nerve stimulation could reduce pain during propofol injection.

in minimizing propofol injection pain.

详细描述

Twenty min after transcutaneous electrical nerve stimulation, the electrodes were removed and propofol 0.5 mg/kg was administered at the rate of 0.5 ml/sec using syringe pump. Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale: 0=no (negative response to questioning), 1=mild pain (pain reported only in response to questioning without any behavioral sings), 2=moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontaneously without questioning, 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears).

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
Single (Investigator)

盲法说明

Two electrodes were attached to the radial side of dominant forearm. In the placebo group the TENS device had no current output although the power "on" indicator light remained active.

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • American Society of Anesthesiologists physical status classification > 3
  • Patient with a history of allergy to drugs
  • Patient who takes opioid, sedative, anticonvulsant
  • Patient with a history of neurologic disease and psychological disorders
  • patient with skin problem
  • Patient with pacemaker or electric medical device
  • pregnancy

结局指标

主要结局

pain during propofol injection

时间窗: 15 seconds

Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Younghoon Jeon

Professor

Kyungpook National University Hospital

研究点 (2)

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