ClinicalTrials.gg
Status unknownNCT03420560Updated Feb 5, 2018

A Warmer Temperature Decrease Propofol Injection Pain

An interventional study of warmer temperature in Injection Site Irritation, Propofol Syndrome and Temperature Change, Body, sponsored by Xingui Dai. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Xingui Dai · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Injection Site Irritation
  • Propofol Syndrome
  • Temperature Change, Body
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 68 interventional studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

Xingui Dai is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • a history of allergy to propofol, allergy to soybean oil
  • with peripheral blood diseases.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Behavioralwarmer temperature

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

06

What researchers measure

Primary outcomes

  1. intensity of injection pain

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

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Chenzhou No.1 People's hopital
    Chenzhou, Hunan 423000, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2018; primary completion for Feb 2018, 0 months later.

Of 44 non-industry interventional studies with no phase under Body Temperature Changes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 0 months is below that.

Counting every sponsor, half of 44 studies reached it within 5 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2018
First posted
Feb 5, 2018
StartEst.
Feb 28, 2018
Primary completionEst.
Feb 28, 2018
CompletionEst.
Apr 30, 2018
Last update
Feb 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03420560
Lead sponsor
Xingui Dai
Responsible party
Xingui Dai (MD, First People's Hospital of Chenzhou) — Sponsor-investigator
First posted
Feb 5, 2018
Start date
Feb 28, 2018 (estimated)
Primary completion
Feb 28, 2018 (estimated)
Completion
Apr 30, 2018 (estimated)
Last update
Feb 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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