UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021412 |
|---|---|
| Receipt number | R000024697 |
| Scientific Title | Influence of saline flush with/without dilution on the effect of rocuronium at corrugator supercilii |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2021/03/21 11:45:16 |
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Basic information
Public title
Influence of saline flush with/without dilution on the effect of rocuronium at corrugator supercilii
Acronym
Rocuronium effect at corrugator supercilii
Scientific Title
Influence of saline flush with/without dilution on the effect of rocuronium at corrugator supercilii
Scientific Title:Acronym
Rocuronium effect at corrugator supercilii
Region
| Japan |
Condition
Condition
patients for elective surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the influence of following saline flush with or without dilution on the effect of rocuronium
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
T1 height and train of four ratio at corrugator supercilii during general anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
undiluted rocuronium administered during anesthesia induction
Interventions/Control_2
undiluted rocuronium followed by 20 mL saline flush during anesthesia induction
Interventions/Control_3
diluted rocuronium followed by 20 mL saline flush during anesthesia induction
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 undergoing elective surgery under general anesthesia
Key exclusion criteria
a history of allergy to neuromuscular blockade, morbid obesity, severe hepatic, renal, or cardiovascular disease, neuromuscular disease, and those receiving medications known to influence neuromuscular function
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
National Defense Medical College
Division name
Anesthesiology
Zip code
359-0042
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
TEL
04-2995-1511
kenichi@masuinet.com
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
National Defense Medical College
Division name
Anesthesiology
Zip code
359-0042
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
TEL
04-2995-1511
Homepage URL
kenichi@masuinet.com
Sponsor or person
Institute
Department of Anesthesiology, National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, National Defense Medical College
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
National Defense Medical College IRB
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
Tel
04-2995-1211
ins010@ndmc.ac.jp
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
| 2016 | Year | 04 | Month | 01 | 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
84
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 09 | Day |
Last modified on
| 2021 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024697
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/03/21 | 研究計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
