A Warmer Temperature Decrease Propofol Injection Pain

NCT03420560 | Unknown

• 1 other identifier: Warm Decrease Pain
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Injection Site Irritation; Propofol Syndrome; Temperature Change, Body

Outcome Measures

Primary Outcomes (3)

• intensity of injection pain

  intensity of injection pain was reported by patient themselves before loss their awareness.

  3 months

• 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

• 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

Study Arms (2)

warmer temperature

EXPERIMENTAL

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

normal temperature

PLACEBO COMPARATOR

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

Interventions

warmer temperature BEHAVIORAL

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

normal temperature; warmer temperature

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I\~III, aged 18，scheduled or emergency surgery with general anesthesia.

You may not qualify if:

• a history of allergy to propofol, allergy to soybean oil
• with peripheral blood diseases.

Sponsors & Collaborators

• Xingui Dai: lead

Study Sites (1)

Chenzhou No.1 People's hopital

Chenzhou, Hunan, 423000, China

RECRUITING

MeSH Terms

Conditions

Propofol Infusion Syndrome; Body Temperature Changes

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 5, 2018
• Study Start: February 28, 2018
• Primary Completion: February 28, 2018
• Study Completion: April 30, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

CN (1)