UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012431 |
|---|---|
| Receipt number | 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 14:24:41 |
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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 | Obstetrics 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
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
keiyumasui@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Keiyu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014531
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