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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025218
Receipt No. 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

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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
Email 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
Email kitajima.osamu@nihon-u.ac.jp

Sponsor
Institute Department of Anesthesiology
Nihon University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027010

Research Plan
Registered date File name
2017/12/12 臨床研究ver2 研究計画書スガマデクス修正申請用.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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