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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021412
Receipt No. R000024697
Scientific Title Influence of saline flush with/without dilution on the effect of rocuronium at corrugator supercilii
Date of disclosure of the study information 2016/04/01
Last modified on 2016/04/18

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Basic information
Public title Influence of saline flush with/without dilution on the effect of rocuronium at corrugator supercilii
Acronym Rocuronium effect at corrugator supercilii
Scientific Title Influence of saline flush with/without dilution on the effect of rocuronium at corrugator supercilii
Scientific Title:Acronym Rocuronium effect at corrugator supercilii
Region
Japan

Condition
Condition patients for elective surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the influence of following saline flush with or without dilution on the effect of rocuronium
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes T1 height and train of four ratio at corrugator supercilii during general anesthesia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 undiluted rocuronium administered during anesthesia induction
Interventions/Control_2 undiluted rocuronium followed by 20 mL saline flush during anesthesia induction
Interventions/Control_3 diluted rocuronium followed by 20 mL saline flush during anesthesia induction
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

Not applicable
Gender Male and Female
Key inclusion criteria patients undergoing elective surgery under general anesthesia
Key exclusion criteria a history of allergy to neuromuscular blockade, morbid obesity, severe hepatic, renal, or cardiovascular disease, neuromuscular disease, and those receiving medications known to influence neuromuscular function
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Masui
Organization National Defense Medical College
Division name Anesthesiology
Zip code
Address Namiki 3-2, Tokorozawa, Saitama, Japan
TEL 04-2995-1511
Email kenichi@masuinet.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Masui
Organization National Defense Medical College
Division name Anesthesiology
Zip code
Address Namiki 3-2, Tokorozawa, Saitama, Japan
TEL 04-2995-1511
Homepage URL
Email kenichi@masuinet.com

Sponsor
Institute Department of Anesthesiology, National Defense Medical College
Institute
Department

Funding Source
Organization Department of Anesthesiology, National Defense Medical College
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 04 Month 01 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
2016 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2016 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
2016 Year 03 Month 09 Day
Last modified on
2016 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024697

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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