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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007647
Receipt No. R000009018
Scientific Title Evaluation of repeated clinical dose of rocuronium after reversal of neuromuscular block by sugammadex within a short time in re-surgical patients.
Date of disclosure of the study information 2012/05/01
Last modified on 2016/10/05

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Basic information
Public title Evaluation of repeated clinical dose of rocuronium after reversal of neuromuscular block by sugammadex within a short time in re-surgical patients.
Acronym Evaluation of repeated clinical dose of rocuronium after reversal of neuromuscular block by sugammadex within a short time in re-surgical patients.
Scientific Title Evaluation of repeated clinical dose of rocuronium after reversal of neuromuscular block by sugammadex within a short time in re-surgical patients.
Scientific Title:Acronym Evaluation of repeated clinical dose of rocuronium after reversal of neuromuscular block by sugammadex within a short time in re-surgical patients.
Region
Japan

Condition
Condition patients who required re-surgery within a short time after using sugammadex.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the optimal dose of second administration of Rocuronium after clinically recommended dose of Sugammadex reversal in re-surgical patients.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time from administration of second Rocuronium to maximum depression of T1 height at the re-surgery.
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 Patients who required re-surgery within 12hours after neuromuscular block reversal by Sugammadex.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who required re-surgery within 12hours after neuromuscular block reversal by Sugammadex.
Key exclusion criteria patients with full stomach or with difficult airway.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Iwasaki
Organization Asahikawa Medical University
Division name Anesthesiology and Critical Care Medicine
Zip code
Address higashi2-1-1-1 Midorigaoka, Asahikawa, Hokkaido, Japan
TEL 0166-65-2111
Email hiwasaki@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Iwasaki
Organization Asahikawa Medical University
Division name Anesthesiology and Critical Care Medicine
Zip code
Address 2-1-1-1 Midorigaoka-higashi Asahikawa Hokkaido
TEL 0166-65-2111
Homepage URL
Email iwasakih@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 02 Day
Last modified on
2016 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009018

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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