UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027061 |
|---|---|
| Receipt number | R000031018 |
| Scientific Title | The effect of neuromuscular blocking agents on the management of mechaninal ventilation with supraglottic airway device and the influence of the differences between anesthetic agents or supraglottic airway devices |
| Date of disclosure of the study information | 2017/04/20 |
| Last modified on | 2018/10/22 09:56:28 |
* 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
The effect of neuromuscular blocking agents on the management of mechaninal ventilation with supraglottic airway device and the influence of the differences between anesthetic agents or supraglottic airway devices
Acronym
The effect of NMBAs on the management of mechaninal ventilation with SGA devices
Scientific Title
The effect of neuromuscular blocking agents on the management of mechaninal ventilation with supraglottic airway device and the influence of the differences between anesthetic agents or supraglottic airway devices
Scientific Title:Acronym
The effect of NMBAs on the management of mechaninal ventilation with SGA devices
Region
| Japan |
Condition
Condition
Patients scheduled for elective surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the proper dosage of rocuronium to decrease the leakage volume during mechanical ventilation with supraglottic airway devices.
To investigate the influence of different anesthetic agents or supraglottic airway devices on this dosage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the decreased leakage volume after rocuronium administration between different dose of rocuronium administrated groups
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
rocuronium dose
Interventions/Control_2
types of anesthetic drugs
Interventions/Control_3
types of supraglottic airway devices
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 scheduled for elective surgery under general anesthesia
Key exclusion criteria
morbidly obese(BMI>=35 kg/m2)
gastroeshophageal reflux
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Fujimoto |
Organization
Nishinihon Hospital
Division name
department of anesthesiology
Zip code
Address
3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto, Japan
TEL
096-380-1111
mfujimoto-kmm@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Fujimoto |
Organization
Nishinihon Hospital
Division name
department of anesthesiology
Zip code
Address
3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto, Japan
TEL
096-380-1111
Homepage URL
mfujimoto-kmm@umin.ac.jp
Sponsor or person
Institute
Nishinihon 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
西日本病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 20 | 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
| 2017 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 20 | 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
| 2017 | Year | 04 | Month | 19 | Day |
Last modified on
| 2018 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031018
