UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025218 |
|---|---|
| Receipt number | R000027010 |
| Scientific Title | Sugammadex doses for effective dose - reaction comparative study for the reversal of neuromuscular blockade induced by rocuronium. |
| Date of disclosure of the study information | 2016/12/10 |
| Last modified on | 2019/08/22 11:35:19 |
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Basic information
Public title
Sugammadex doses for effective dose - reaction comparative study for the reversal of neuromuscular blockade induced by rocuronium.
Acronym
Sugammadex doses for effective dose - reaction comparative study for the reversal of neuromuscular blockade induced by rocuronium.
Scientific Title
Sugammadex doses for effective dose - reaction comparative study for the reversal of neuromuscular blockade induced by rocuronium.
Scientific Title:Acronym
Sugammadex doses for effective dose - reaction comparative study for the reversal of neuromuscular blockade induced by rocuronium.
Region
| Japan |
Condition
Condition
Patients scheduled for elective surgery requiring general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dose-response comparative study on Sugammadex effective dose in the reversal of moderate rocuronium-induced neuromuscular blockade
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 95% effective dose of Sugammadex
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sugammadex are administered
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the patients scheduled for elective surgery requiring general anesthesia
the patients were ASA physical status 1-3
Key exclusion criteria
the patients were ASA physical status 4-6
the patients who have renal or neuromuscular disorders
the patients who are scheduled hepatic or renal surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | OSAMU |
| Middle name | |
| Last name | KITAJIMA |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1,Oyaguchi,kamimati,Itabasi-ku,Tokyo
TEL
81339728111
kitajima.osamu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | OSAMU |
| Middle name | |
| Last name | KITAJIMA |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1,Oyaguchi,kamimati,Itabasi-ku,Tokyo
TEL
81339728111
Homepage URL
kitajima.osamu@nihon-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology
Nihon University School of Medicine
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
Nihon University School of Medicine
Address
30-1,Oyaguchi,kamimati,Itabasi-ku,Tokyo
Tel
81339728111
kitajima.osamu@nihon-u.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 | 12 | Month | 10 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 10 | Day |
Last modified on
| 2019 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027010
