A Warmer Temperature Decrease Propofol Injection Pain

Sponsor

Xingui Dai (Other)

Overall Status

Unknown status

CT.gov ID

NCT03420560

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

59.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Injection Site Irritation Propofol Syndrome Temperature Change, Body	Behavioral: warmer temperature	N/A

Study Design

Study Type:

Interventional

Anticipated 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.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

Anticipated Study Start Date :

Feb 28, 2018

Anticipated Primary Completion Date :

Feb 28, 2018

Anticipated Study Completion Date :

Apr 30, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

intensity of injection pain [3 months]
intensity of injection pain was reported by patient themselves before loss their awareness.
numbers of lidocaine rescues for severe injection pain [3 months]
when unbearable injection happens,patient could ask for stop and 20mg lidocaine was injected as rescue treatments.
incidences of injection pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chenzhou No.1 People's hopital	Chenzhou	Hunan	China	423000

Sponsors and Collaborators

Xingui Dai

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xingui Dai, MD, First People's Hospital of Chenzhou

ClinicalTrials.gov Identifier:

NCT03420560

Other Study ID Numbers:

Warm Decrease Pain

First Posted:

Feb 5, 2018

Last Update Posted:

Feb 5, 2018

Last Verified:

Jan 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Body Temperature Changes

Propofol Infusion Syndrome

Study Results

No Results Posted as of Feb 5, 2018