UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007254 |
|---|---|
| Receipt number | R000008554 |
| Scientific Title | Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study |
| Date of disclosure of the study information | 2012/02/21 |
| Last modified on | 2012/02/09 12:10:47 |
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Basic information
Public title
Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study
Acronym
Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study
Scientific Title
Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study
Scientific Title:Acronym
Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study
Region
| Japan |
Condition
Condition
Psychiatric disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to evaluate muscular relaxant reverse effect of sugammadex for rocuronium.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reversal effect of sugammadex for rocuronium induced neuromuscular block
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
To evaluate dose response muscular blockade reversal effect, 2 mg/kg of sugammadex will be assigned.
Interventions/Control_2
To evaluate dose response muscular blockade reversal effect, 4 mg/kg of sugammadex will be assigned.
Interventions/Control_3
To evaluate dose response muscular blockade reversal effect, 8 mg/kg of sugammadex will be assigned.
Interventions/Control_4
To evaluate dose response muscular blockade reversal effect, 16 mg/kg of sugammadex will be assigned.
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
1. Patients who will be planned electroconvulsive therapy
2. Patients who are capable of providing written informed consent.
Key exclusion criteria
Patients seems inadequate for this study by investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Ozaki |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
8-1 Kawada-cho Shinjuku-ku, Tokyo
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
8-1 Kawada-cho Shinjuku-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 21 | 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
| 2012 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 09 | Day |
Last modified on
| 2012 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008554
