Injection Site IrritationNCT03420560
A Warmer Temperature Decrease Propofol Injection Pain
A study testing warmer temperature in people with Injection Site Irritation and Propofol Syndrome, run by Xingui Dai at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Injection Site Irritation, Propofol Syndrome, Temperature Change, Body
- What is being tested?
- warmer temperature
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2018to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I~III, aged 18，scheduled or emergency surgery with general anesthesia.
Who cannot join
- a history of allergy to propofol, allergy to soybean oil
- with peripheral blood diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chenzhou No.1 People's hopital
Chenzhou, Hunan, 423000
Zhiming Zhang, MD.Ph.D, +8613875555649, otc0735@163.com
About this study
Official title: 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.
- Being tested
- warmer temperature
- Medical subject headings
- Propofol Infusion Syndrome, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warmer temperatureBehavioural
Patients before general anesthesia induction will send to warmer operation Injection pain was accessed with (Visual analogous scale)VAS.
| Study group | Role | What they receive |
|---|---|---|
| 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℃). Receives: 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). Receives: Behavioral: warmer temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity of injection pain
intensity of injection pain was reported by patient themselves before loss their awareness.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start28 Feb 2018 (estimated)
- Primary completion28 Feb 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site IrritationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xingui Dai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingui Dai, First People's Hospital of Chenzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420560
- Sponsor's protocol ID
- Warm Decrease Pain
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Warmer Room-temperature at 27-28 Centi-degree Will Decrease Propofol Injection Pain
- ClinicalTrials.gov ID
- NCT03420560
- Acronym / sponsor ID
- Warm Decrease Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xingui DaiUniversity, hospital or other
- Study start
- 28 Feb 2018 (estimated)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| warmer temperature | Experimental | Behavioral: warmer temperatureTo compare the incidence and intensity of pain on injection that is caused by propofol in warm temperature（27℃） versus normal temperature(23℃). |
| normal temperature | Placebo comparator | Behavioral: warmer temperatureThe 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I~III, aged 18，scheduled or emergency surgery with general anesthesia.
Key exclusion criteria (2 listed)
- a history of allergy to propofol, allergy to soybean oil
- with peripheral blood diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warmer temperaturePatients before general anesthesia induction will send to warmer operation Injection pain was accessed with (Visual analogous scale)VAS. | Behavioural | normal temperature, warmer temperature |
Primary outcome
intensity of injection pain
Time frame: 3 months
intensity of injection pain was reported by patient themselves before loss their awareness.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warmer temperature in people with Injection Site Irritation and Propofol Syndrome, run by Xingui Dai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensity of injection pain (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.