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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020599
Receipt No. 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

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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
Email 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
Email kida0430@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa medical university
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023777

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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