A Warmer Temperature Decrease Propofol Injection Pain

February 1, 2018 updated by: Xingui Dai

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Chenzhou, Hunan, China, 423000
        • Recruiting
        • Chenzhou No.1 People's hopital
        • Contact:
          • Zhiming Zhang, MD.Ph.D
          • Phone Number: +8613875555649
          • Email: otc0735@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: warmer temperature
To compare the incidence and intensity of pain on injection that is caused by propofol in warm temperature（27℃） versus normal temperature(23℃).
Behavioral: warmer temperature
Patients before general anesthesia induction will send to warmer operation Injection pain was accessed with (Visual analogous scale)VAS.
Placebo Comparator: normal temperature
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).
Behavioral: warmer temperature
Patients before general anesthesia induction will send to warmer operation Injection pain was accessed with (Visual analogous scale)VAS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intensity of injection pain
Time Frame: 3 months
intensity of injection pain was reported by patient themselves before loss their awareness.
3 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xingui Dai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 28, 2018

Primary Completion (Anticipated)

February 28, 2018

Study Completion (Anticipated)

April 30, 2018

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Warm Decrease Pain

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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