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A Warmer Temperature Decrease Propofol Injection Pain

Primary Purpose

Injection Site Irritation, Propofol Syndrome, Temperature Change, Body

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
warmer temperature
Sponsored by
Xingui Dai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Injection Site Irritation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chenzhou No.1 People's hopitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

warmer temperature

normal temperature

Arm Description

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

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).

Outcomes

Primary Outcome Measures

intensity of injection pain
intensity of injection pain was reported by patient themselves before loss their awareness.
numbers of lidocaine rescues for severe injection pain
when unbearable injection happens,patient could ask for stop and 20mg lidocaine was injected as rescue treatments.
incidences of injection pain
Numeric Visual Analog Scale of injection >2 was counted as injection pain happens,the total incidence of injection was compared in two groups.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2018
Last Updated
February 1, 2018
Sponsor
Xingui Dai
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1. Study Identification

Unique Protocol Identification Number
NCT03420560
Brief Title
A Warmer Temperature Decrease Propofol Injection Pain
Official Title
A Warmer Room-temperature at 27-28 Centi-degree Will Decrease Propofol Injection Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2018 (Anticipated)
Primary Completion Date
February 28, 2018 (Anticipated)
Study Completion Date
April 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xingui Dai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injection Site Irritation, Propofol Syndrome, Temperature Change, Body

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients for observation will sent to a warmer operating room,while Patients in controled Group will send to normal setting operating room at about 23 centigrade.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
warmer temperature
Arm Type
Experimental
Arm Description
To compare the incidence and intensity of pain on injection that is caused by propofol in warm temperature(27℃) versus normal temperature(23℃).
Arm Title
normal temperature
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
warmer temperature
Intervention Description
Patients before general anesthesia induction will send to warmer operation Injection pain was accessed with (Visual analogous scale)VAS.
Primary Outcome Measure Information:
Title
intensity of injection pain
Description
intensity of injection pain was reported by patient themselves before loss their awareness.
Time Frame
3 months
Title
numbers of lidocaine rescues for severe injection pain
Description
when unbearable injection happens,patient could ask for stop and 20mg lidocaine was injected as rescue treatments.
Time Frame
3 months
Title
incidences of injection pain
Description
Numeric Visual Analog Scale of injection >2 was counted as injection pain happens,the total incidence of injection was compared in two groups.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chenzhou No.1 People's hopital
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Zhang, MD.Ph.D
Phone
+8613875555649
Email
otc0735@163.com

12. IPD Sharing Statement

Learn more about this trial

A Warmer Temperature Decrease Propofol Injection Pain

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