UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effect that EMLA cream gives for a rocronium dosage time ache.
Title of the study (Brief title)	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	Daisuke Sugiyama
Organization	Shinshu University
Division name	Department of Anesthesiology and Resuscitology
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2670
Email	sugidai@shinshu-u.ac.jp

Public contact
Name of contact person	Daisuke Sugiyama
Organization	Shinshu University
Division name	Department of Anesthesiology and Resuscitology
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2670
Homepage URL
Email	sugidai@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015289