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Clinical Trials/NCT03420560
NCT03420560UnknownNot Applicable

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

Xingui Dai1 site in 1 country120 target enrollmentStarted: February 28, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
incidences of injection pain

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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℃).

Intervention: 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).

Intervention: warmer temperature (Behavioral)

Outcomes

Primary Outcomes

incidences of injection pain

Time Frame: 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

Time Frame: 3 months

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

numbers of lidocaine rescues for severe injection pain

Time Frame: 3 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Xingui Dai
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Xingui Dai

MD

First People's Hospital of Chenzhou

Study Sites (1)

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