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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012431
Receipt No. R000014531
Scientific Title Which is more useful in non-obese patients (BMI<30) undergoing tracheal intubation, T1% of the corrugator supercilii muscle, or effect site concentration of rocuronium calculated by the iPad application AnestAssist ?
Date of disclosure of the study information 2013/11/28
Last modified on 2014/11/05

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Basic information
Public title Which is more useful in non-obese patients (BMI<30) undergoing tracheal intubation, T1% of the corrugator supercilii muscle, or effect site concentration of rocuronium calculated by the iPad application AnestAssist ?
Acronym Which is more useful in non-obese patients undergoing tracheal intubation, T1% of the corrugator supercilii muscle, or effect site concentration of rocuronium ?
Scientific Title Which is more useful in non-obese patients (BMI<30) undergoing tracheal intubation, T1% of the corrugator supercilii muscle, or effect site concentration of rocuronium calculated by the iPad application AnestAssist ?
Scientific Title:Acronym Which is more useful in non-obese patients undergoing tracheal intubation, T1% of the corrugator supercilii muscle, or effect site concentration of rocuronium ?
Region
Japan

Condition
Condition Diseases which require elective surgery under general anesthesia
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Breast surgery Obsterics and gynecology
Ophthalmology Oto-rhino-laryngology Orthopedics
Urology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our purpose is to investigate whether effect site concentration of rocuronium calculated by iPad application AnestAssist is more useful to non-obese patients (BMI<30) than T1% of the corrugator supercilii muscle.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes T1% of the corrugator supercilii muscle, effect site concentration of rocurronium calculated by software, and tracheal intubation condition
Key secondary outcomes What patient characteristics affect tracheal intubation condition?

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 7
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients who are given rocuronium 0.6mg/kg before tracheal intubation
Interventions/Control_2 Patients who are given rocuronium 0.7mg/kg before tracheal intubation
Interventions/Control_3 Patients who are given rocuronium 0.8mg/kg before tracheal intubation
Interventions/Control_4 Patients who are given rocuronium 0.9mg/kg before tracheal intubation
Interventions/Control_5 Patients who are given rocuronium 1.0mg/kg before tracheal intubation
Interventions/Control_6 Patients who are given rocuronium 1.1mg/kg before tracheal intubation
Interventions/Control_7 Patients who are given rocuronium 1.2mg/kg before tracheal intubation
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Non-obese patients undergoing elective surgery under general anesthesia (BMI<30)
Key exclusion criteria 1. When it is difficult to intubate, the patient is excluded.
2. When it is impossible to calibrate TOF-Watch, the patient is excluded.
3. When unexpected complications occur, the patient is excluded.
Target sample size 165

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MASATO SATO
Organization Keiyu Hospital
Division name Department of Anesthesiology
Zip code
Address 3-7-3 Minatomirai Nishiku Yokohama Japan
TEL 045-221-8181
Email keiyumasui@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name MASATO SATO
Organization Keiyu Hospital
Division name Department of Anesthesiology
Zip code
Address 3-7-3 Minatomirai Nishiku Yokohama Japan
TEL 045-221-8181
Homepage URL
Email keiyumasui@gmail.com

Sponsor
Institute Department of Anesthesiology, Keiyu Hospital
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 けいゆう病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 1. T1% of the corrugator supercilii is not useful to non-obese patients undergoing tracheal intubation.
2. Effect site concentration of rocuronium calculated by software is more useful than T1% of the corrugator supercilii.
3. Effect site concentration of rocuronium should be adjusted by patient gender and BMI.
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
2013 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 29 Day
Last follow-up date
2014 Year 07 Month 29 Day
Date of closure to data entry
2014 Year 07 Month 29 Day
Date trial data considered complete
2014 Year 07 Month 29 Day
Date analysis concluded
2014 Year 07 Month 29 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 28 Day
Last modified on
2014 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014531

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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