UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013107 |
|---|---|
| Receipt number | R000015289 |
| Scientific Title | Examination of the effect that EMLA cream gives for a rocronium dosage time ache. |
| Date of disclosure of the study information | 2014/02/07 |
| Last modified on | 2017/08/11 09:04:49 |
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Basic information
Public title
Examination of the effect that EMLA cream gives for a rocronium dosage time ache.
Acronym
Examination of the effect that EMLA cream gives for a rocronium dosage time ache.
Scientific Title
Examination of the effect that EMLA cream gives for a rocronium dosage time ache.
Scientific Title:Acronym
Examination of the effect that EMLA cream gives for a rocronium dosage time ache.
Region
| Japan |
Condition
Condition
The patient who has an operation under anesthesia in our hospital.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When I perform tracheal intubation, the dosage of the muscle relaxant is necessary for general anesthesia. Action time of onset is early as muscle relaxant, and rocuronium which duration of action has a short is generally used now. It is said that rocuronium has a strong pain in the dosage and may be accompanied by body movement in the dosage. I am in danger of an intravenous feeding false withdrawal, a gastric content countercurrent, the aspiration by body movement. Various methods (opioid, the intravenous precedent dosage of the local anesthetic) are performed as a method to reduce a rocuronium dosage time ache. However, a circulation change may become unstable by the precedent drug dosage, and it is difficult to give the precedent dosage for all cases. The EMLA cream which was lidocaine propitocaine combination cream was released in Japan in 2013. This drug has adaptation for painkilling with the laser treatment. It is intended to consider whether you can reduce a rocuronium dosage time ache by applying EMLA cream to skin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate it by sharp pain score, a vital change after the rocuronium dosage.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group: application posterior vein secures a basis from the back of hand to the forearm.
Interventions/Control_2
Emura group: application posterior vein from the EMLA cream back of hand to the forearm 45 minutes before venepuncture
Interventions/Control_3
Interventions/Control_4
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Planned operation patient under the general anesthesia
Key exclusion criteria
The patient who uses a local anesthetic before general anesthesia.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Sugiyama |
Organization
Shinshu University
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2670
sugidai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sugiyama |
Organization
Shinshu University
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2670
Homepage URL
sugidai@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
Address
Tel
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
| 2014 | Year | 02 | Month | 07 | 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
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
| 2014 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 07 | Day |
Last modified on
| 2017 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015289
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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