UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021078
Receipt number R000024301
Scientific Title Activation of TRPM8 with cooling and application of menthol can reduce propofol injection-induced pain
Date of disclosure of the study information 2016/02/17
Last modified on 2019/08/29 13:05:08

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Basic information

Public title

Activation of TRPM8 with cooling and application of menthol can reduce propofol injection-induced pain

Acronym

Activation of TRPM8 with cooling and application of menthol can reduce propofol injection-induced pain

Scientific Title

Activation of TRPM8 with cooling and application of menthol can reduce propofol injection-induced pain

Scientific Title:Acronym

Activation of TRPM8 with cooling and application of menthol can reduce propofol injection-induced pain

Region

Japan


Condition

Condition

The patient whowere scheduled for elective surgery under anesthesia in our hospital.

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Injection of propofol has a high potential to induce intense burning pain. Since skin cooling is known to reduce burning pain originated from both the skin and deep tissue, and since the analgesic effect of skin cooling is known to depend on the activation of transient receptor potential M8 (TRPM8), we hypothesised that cooling the skin can prevent propofol injection-induced pain via activation of TRPM8 in the skin.
We first examined whether cooling of the skin can prevent propofol injection-induced pain or not. If so, we then would try to examine whether application of topical TRPM8 agonist (menthol) on the skin can prevent propofol injection-induced pain or not.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

During the injection of propofol,we assess the incidence and intensity of propofol injection-induced pain and a 4-point numerical rating scales.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine Other

Interventions/Control_1

In Group non-cooling, a cooling gel pad stored at room temperature was applied on the left side of forearm.

Interventions/Control_2

In Group cooling, a cooling gel pad stored at 7 degree was applied on the left side of forearm.

Interventions/Control_3

In Group menthol, 1 ml of 30% menthol dissolved in 70% ethanol was applied to the left side of forearm.

Interventions/Control_4

In Group solvent, 1 ml of 70% ethanol was applied to the left side of forearm.

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Planned operation patient under the general anesthesia.

Key exclusion criteria

1.Patients administered an analgesic before operation.
2.Patients have an allergy to propofol.
3.Patients have an allergy to ethanol.
4.Patients who have a skin disease to the arms.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Ishida

Organization

Shinshu University

Division name

Department of Anesthesiology and Resuscitology

Zip code

3908621

Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-37-2670

Email

tisd@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Maiko
Middle name
Last name Suzuki

Organization

Shinshu University

Division name

Department of Anesthesiology and Resuscitology

Zip code

3908621

Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-37-2670

Homepage URL


Email

mmw@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shinshu University Certified Review Board of Clinical Research

Address

3-1-1 Asahi, Matsumoto, Nagano

Tel

0263-37-2572

Email

mdrinri@shinshu-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

120

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 02 Month 03 Day

Date of IRB

2016 Year 02 Month 03 Day

Anticipated trial start date

2016 Year 02 Month 22 Day

Last follow-up date

2017 Year 02 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 17 Day

Last modified on

2019 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024301


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name