UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020599 |
|---|---|
| Receipt number | R000023777 |
| Scientific Title | Study of rocuronium onset time shortened |
| Date of disclosure of the study information | 2016/01/18 |
| Last modified on | 2016/01/17 03:29:43 |
* 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
Study of rocuronium onset time shortened
Acronym
Study of rocuronium onset time shortened
Scientific Title
Study of rocuronium onset time shortened
Scientific Title:Acronym
Study of rocuronium onset time shortened
Region
| Japan |
Condition
Condition
General anesthesia target disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To target and non-elderly 20-year-old to 60-year-old and 70-year-old to 85-year-old elderly, effect onset time of rocuronium is to investigate whether to change how with the backing of saline. The push method saline, and selects the method of the lifted containing arms of venous channels by injecting 20mL, the two ways of injecting 40mL. This study, also in the elderly not non-elderly only, quick and safe anesthesia introduction method is established.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shortening of the muscle relaxant effect expression time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group: rocuronium 0.6 mg / kg after the administration, to boost over a 5 mL saline 4 seconds.
Interventions/Control_2
Saline 20 mL groups: rocuronium 0.6 mg / kg after the administration, and to boost the 20 mL saline in 16 seconds, the arm of the injection side to be lifted.
Interventions/Control_3
Saline 40 mL groups: rocuronium 0.6 mg / kg after the administration, to boost the 40 mL saline in 16 seconds.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Tracheal intubation in our hospital operating room, those undergoing surgery under general anesthesia.
Adult men and women 90 patients.
Non-elderly group 45 patients, the elderly group of 45 patients.
ASA-PS1-2(those without systemic disease, or those with mild systemic disease)
Key exclusion criteria
Patients with neuromuscular disorders.
Patients with drugs that interaction with muscle relaxant.
Patient of NYHA3 more.
BMI 25 greater, or 18.5 less of patients.
Chronic renal failure or patient that has been introduced an artificial dialysis.
Cirrhosis patient.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Kida |
Organization
Kanazawa medical university
Division name
Anesthesiology
Zip code
Address
1-1 daigaku utinadamati kahokugun isikawaken
TEL
076-286-3511
kida0430@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Kida |
Organization
Kanazawa medical university
Division name
Anesthesiology
Zip code
Address
1-1 daigaku utinadamati kahokugun isikawaken
TEL
076-286-3511
Homepage URL
kida0430@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa medical university
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 18 | 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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | 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 | 01 | Month | 17 | Day |
Last modified on
| 2016 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023777
