UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017126 |
|---|---|
| Receipt number | R000016002 |
| Scientific Title | Reversal of Neuromuscular Blockade with Sugammadex Based on the Residual of Rocuronium in the Body |
| Date of disclosure of the study information | 2015/04/13 |
| Last modified on | 2018/04/16 06:26:13 |
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Basic information
Public title
Reversal of Neuromuscular Blockade with Sugammadex Based on the Residual of Rocuronium in the Body
Acronym
Reversal of Neuromuscular Blockade with Sugammadex Based on the Residual of Rocuronium in the Body
Scientific Title
Reversal of Neuromuscular Blockade with Sugammadex Based on the Residual of Rocuronium in the Body
Scientific Title:Acronym
Reversal of Neuromuscular Blockade with Sugammadex Based on the Residual of Rocuronium in the Body
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
Evaluation of the reversal of the neuromuscular blockade with sugammadex which dose was calculated from the residual of rocuronium using pharmacokinetic simulation
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of neuromuscular responses with a peripheral neurostimulator
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the group in which sugammadex are administered 2mg/kg
Interventions/Control_2
the group in which sugammadex are administered 4 times the residual amount of rocuronium
Interventions/Control_3
the group in which sugammadex are administered 6 times the residual amount of rocuronium
Interventions/Control_4
the group in which sugammadex are administered 8 times the residual amount of rocuronium
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the patients scheduled for elective surgery requiring general anesthesia
the patients were ASA physical status 1-2
Key exclusion criteria
the patients were ASA physical status 3-4
the patients who have cardiac, hepatic, renal or neuromuscular disorders
the patients who are scheduled hepatic or renal surgery
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Shibuta |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care
Zip code
Address
2-2, Yamadaoka, Suita-shi, Osaka, Japan
TEL
+81-6-6879-3133
shibuta@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomotaka Morita |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care
Zip code
Address
2-2, Yamadaoka, Suita-shi, Osaka, Japan
TEL
+81-6-6879-3133
Homepage URL
tmorita@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 13 | 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
| 2013 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 13 | Day |
Last modified on
| 2018 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016002
