UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032466 |
|---|---|
| Receipt number | 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 11:17:20 |
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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
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
tachi@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037011
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
