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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032466
Receipt No. R000037011
Scientific Title Comparision of ESLAX Intravenous with Rocuronium Bromide Intravenous Solution in the incident of pain on injection
Date of disclosure of the study information 2018/05/07
Last modified on 2019/07/07

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Basic information
Public title Comparision of ESLAX Intravenous with Rocuronium Bromide Intravenous Solution in the incident of pain on injection
Acronym Comparision of ESLAX Intravenous with Rocuronium Bromide Intravenous Solution in the incident of pain on injection
Scientific Title Comparision of ESLAX Intravenous with Rocuronium Bromide Intravenous Solution in the incident of pain on injection
Scientific Title:Acronym Comparision of ESLAX Intravenous with Rocuronium Bromide Intravenous Solution in the incident of pain on injection
Region
Japan

Condition
Condition Patients undergoing elective surgery requiring general anesthesia and tracheal intubation
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compared pain on injection of ESLAX Intravenous with Rocuronium Bromide Intravenous Solution
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient response after rocuronium injection
Key secondary outcomes The degree of patient response after rocuronium injection, and the result of tracheal intubation.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ESLAX Intravenous
Interventions/Control_2 Rocuronium Bromide Intravenous Solution
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Patients aged between 20 and 65 year,ASA physical status 1 or 2
Key exclusion criteria patient with chronic pain
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Okuda Yasuhisa
Organization Dokkyo Medical University Saitama Medical Center
Division name Anesthesiology
Zip code
Address 2-1-50 Minamikoshigaya Koshigayashi Saitama
TEL 0489654948
Email tachi@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tachikawa Masato
Organization Dokkyo Medical University Saitama Medical Center
Division name Anesthesiology
Zip code
Address 2-1-50 Minamikoshigaya Koshigayashi Saitama
TEL 0489654948
Homepage URL
Email tachi@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization none
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
Email

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
2018 Year 05 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 60
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
2018 Year 04 Month 01 Day
Date of IRB
2018 Year 02 Month 21 Day
Anticipated trial start date
2018 Year 05 Month 07 Day
Last follow-up date
2019 Year 01 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 02 Day
Last modified on
2019 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037011

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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