UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007276
Receipt No. R000008545
Scientific Title Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients
Date of disclosure of the study information 2012/03/01
Last modified on 2015/08/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients
Acronym Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients
Scientific Title Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients
Scientific Title:Acronym Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients
Region
Japan

Condition
Condition Surgical pediatric patients undergoing general anesthesia
Classification by specialty
Surgery in general Ophthalmology Oto-rhino-laryngology
Orthopedics Urology Anesthesiology
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to determine the necessity of additional Sugammadex in a short post-operative period.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes It is possible to determine the necessity of additional Sugammadex for the complete reversal of neuromuscular block in a short post-operative period.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sufficient group
Interventions/Control_2 insufficient group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
0 years-old <=
Age-upper limit
10 years-old >=
Gender Male and Female
Key inclusion criteria surgical pediatric patients undergoing general anesthesia
Key exclusion criteria 1.patients with liver and renal dysfunction
2.patients with neuromuscular disease
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Iwasaki
Organization Asahikawa Medical University
Division name Department of Anesthesiology and critical care medicine
Zip code
Address higashi2-1-1-1 Midorigaoka, Asahikawa, Hokkaido, Japan
TEL 0166682583
Email iwasakih@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Iwasaki
Organization Asahikawa Medical University
Division name Department of Anesthesiology and critical care medicine
Zip code
Address higashi2-1-1-1 Midorigaoka, Asahikawa, Hokkaido, Japan
TEL 0166682583
Homepage URL
Email iwasakih@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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 03 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 No longer recruiting
Date of protocol fixation
2012 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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 02 Month 13 Day
Last modified on
2015 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008545


Contact us.