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A Warmer Temperature Decrease Propofol Injection Pain

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ClinicalTrials.gov Identifier: NCT03420560
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Xingui Dai, First People's Hospital of Chenzhou

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.


Condition or disease Intervention/treatment Phase
Injection Site Irritation Propofol Syndrome Temperature Change, Body Behavioral: warmer temperature Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: 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.
Primary Purpose: Prevention
Official Title: A Warmer Room-temperature at 27-28 Centi-degree Will Decrease Propofol Injection Pain
Estimated Study Start Date : February 28, 2018
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

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.




Primary Outcome Measures :
  1. intensity of injection pain [ Time Frame: 3 months ]
    intensity of injection pain was reported by patient themselves before loss their awareness.

  2. 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. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420560


Locations
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China, Hunan
Chenzhou No.1 People's hopital Recruiting
Chenzhou, Hunan, China, 423000
Contact: Zhiming Zhang, MD.Ph.D    +8613875555649    otc0735@163.com   
Sponsors and Collaborators
Xingui Dai

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Responsible Party: Xingui Dai, MD, First People's Hospital of Chenzhou
ClinicalTrials.gov Identifier: NCT03420560     History of Changes
Other Study ID Numbers: Warm Decrease Pain
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

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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

Additional relevant MeSH terms:
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Body Temperature Changes
Propofol Infusion Syndrome
Signs and Symptoms
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics