UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046213 |
|---|---|
| Receipt number | R000052740 |
| Scientific Title | Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control |
| Date of disclosure of the study information | 2021/11/29 |
| Last modified on | 2021/11/29 10:45:38 |
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Basic information
Public title
Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control
Acronym
Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control
Scientific Title
Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control
Scientific Title:Acronym
Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control
Region
| Japan |
Condition
Condition
Condition with surgical indication in general anesthesia
Classification by specialty
| Gastroenterology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Breast surgery | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Cardiovascular surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Compare measured blood concentration with predicted blood concentration of rocuronium in automatic infusion control under four conditions.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measured blood concentration and predicted blood concentration of rocuronium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Collect atrial blood about 5ml at 4 times during surgery.
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient given surgery with total intravenous anesthesia.
Key exclusion criteria
Patient can't use rocuronium, patient have severe liver or renal disfunction.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nakanishi |
| Middle name | |
| Last name | Yuko |
Organization
University of Fukui Hospital
Division name
Department of Anesthesiology and Reanimatology
Zip code
9101193
Address
23-3 Shimoaiduki, Matsuoka, Eiheijicho, Toshida gun, Fukui
TEL
0776613111
honjoh@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Nakanishi |
| Middle name | |
| Last name | Yuko |
Organization
University of Fukui Hospital
Division name
Department of Anesthesiology and Reanimatology
Zip code
9101193
Address
23-3 Shimoaiduki, Matsuoka, Eiheijicho, Toshida gun, Fukui
TEL
0776613111
Homepage URL
honjoh@u-fukui.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Medical research support center
Address
23-3 Shimoaiduki, Matsuoka, Eiheijicho, Toshida gun, Fukui
Tel
0776613111
chiken@ml.u-fukui.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
| 2021 | Year | 11 | Month | 29 | 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
17
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 | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 11 | Month | 29 | Day |
Last modified on
| 2021 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052740
| 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 |
