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临床试验/NCT03420560
NCT03420560Unknown不适用

A Warmer Room-temperature at 27-28 Centi-degree Will Decrease Propofol Injection Pain

Xingui Dai1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
incidences of injection pain

研究概览

简要总结

Propofol injection pain will be surfed by up to 70-80 percentage by the Patients who induced by propofol. Temperature of Operating room was set to a certain range in normal clinical practice, which is 22- 26 centigrade. Warm feeling will make skin vassal dilated and more blood will pass through to bring more heat out of our body. It had been reported that a bigger venous vessels will get less propofol injection pain.

The investigators hypothesis that Patients who stayed in a warmer room temperature will surf less injection pain while compare to a normal setting room temperature.

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
Double (Participant, Outcomes Assessor)

盲法说明

Patients will not knowing the exact temperature of the room,thought they will have their own feeling about it. Data was collecting with a anesthesia nurse who do not know what will do with these data. data were assessed to an anesthesiologist who did not know the Group allocation.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ASA I~III, aged 18,scheduled or emergency surgery with general anesthesia.

排除标准

  • •a history of allergy to propofol, allergy to soybean oil
  • •with peripheral blood diseases.

研究组 & 干预措施

warmer temperature

Experimental

To compare the incidence and intensity of pain on injection that is caused by propofol in warm temperature(27℃) versus normal temperature(23℃).

干预措施: warmer temperature (Behavioral)

normal temperature

Placebo Comparator

The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol in different room temperature(27 VS 23).

干预措施: warmer temperature (Behavioral)

结局指标

主要结局

incidences of injection pain

时间窗: 3 months

Numeric Visual Analog Scale of injection \>2 was counted as injection pain happens,the total incidence of injection was compared in two groups.

intensity of injection pain

时间窗: 3 months

intensity of injection pain was reported by patient themselves before loss their awareness.

numbers of lidocaine rescues for severe injection pain

时间窗: 3 months

when unbearable injection happens,patient could ask for stop and 20mg lidocaine was injected as rescue treatments.

次要结局

未报告次要终点

研究者

发起方
Xingui Dai
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xingui Dai

MD

First People's Hospital of Chenzhou

研究点 (1)

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