UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034556 |
|---|---|
| Receipt number | R000039394 |
| Scientific Title | Effects of preoperative amino acid infusion on the duration of Rocuronium during laparotomy (non-randomized comparative study) |
| Date of disclosure of the study information | 2018/10/18 |
| Last modified on | 2018/10/18 12:13:07 |
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Basic information
Public title
Effects of preoperative amino acid infusion on the duration of Rocuronium during laparotomy (non-randomized comparative study)
Acronym
Effects of amino acid infusion on the duration of Rocuronium
Scientific Title
Effects of preoperative amino acid infusion on the duration of Rocuronium during laparotomy (non-randomized comparative study)
Scientific Title:Acronym
Effects of amino acid infusion on the duration of Rocuronium
Region
| Japan |
Condition
Condition
laparotomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effect of preoperative amino acid infusion on the duration of Rocuronium during laparotomy
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
duration of Rocuronium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are 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
amino acid infusion group
Interventions/Control_2
placebo (saline) control
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients scheduled laparotomy(malignant & non-malignant diseases)
Key exclusion criteria
patients taking drugs which affect the duration of Rocuronium
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Watanabe |
Organization
National Health Organization Mito Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Sakuranosato 280, Ibaraki City, IBARAKI
TEL
029-240-7711
atenza.kazuhirowatanabe@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Watanabe |
Organization
National Health Organization Mito Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Sakuranosato 280, Ibaraki City, IBARAKI
TEL
029-240-7711
Homepage URL
atenza.kazuhirowatanabe@gmail.com
Sponsor or person
Institute
Division of Clinical Research
National Health Organization
Mito Medical Center
Institute
Department
Personal name
Funding Source
Organization
Division of Clinical Research
National Health Organization
Mito Medical Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 10 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 18 | 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
| 2018 | Year | 10 | Month | 18 | Day |
Last modified on
| 2018 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039394
