A Warmer Temperature Decrease Propofol Injection Pain

Temperature Change, Body Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03420560
• Other study ID #: Warm Decrease Pain
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2018
• Last updated: February 1, 2018
• Start date: February 28, 2018
• Est. completion date: April 30, 2018

Study information

• Verified date: January 2018
• Source: First People's Hospital of Chenzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Temperature Changes
• Injection Site Irritation
• Propofol Infusion Syndrome
• Propofol Syndrome
• Temperature Change, Body

Intervention

Behavioral:
• warmer temperature
Patients before general anesthesia induction will send to warmer operation Injection pain was accessed with (Visual analogous scale)VAS.

Locations

Country	Name	City	State
China	Chenzhou No.1 People's hopital	Chenzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xingui Dai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intensity of injection pain	intensity of injection pain was reported by patient themselves before loss their awareness.	3 months
Primary	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.	3 months
Primary	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.	3 months