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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007289
Receipt No. R000008591
Scientific Title Reevaluation of optimal initial dose of rocuronium
Date of disclosure of the study information 2012/02/14
Last modified on 2012/02/14

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Basic information
Public title Reevaluation of optimal initial dose of rocuronium
Acronym Reevaluation of optimal initial dose of rocuronium
Scientific Title Reevaluation of optimal initial dose of rocuronium
Scientific Title:Acronym Reevaluation of optimal initial dose of rocuronium
Region
Japan Asia(except Japan)

Condition
Condition General anesthesia case
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the optimal initial dose of rocuronium for intubation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Train of four, ease of intubation
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 6
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sevoflurane anesthesia + 0.3mg/kg of rocuronium

Interventions/Control_2 sevoflurane anesthesia + 0.6mg/kg of rocuronium
Interventions/Control_3 sevoflurane anesthesia + 0.9mg/kg of rocuronium
Interventions/Control_4 propofol anesthesia + 0.3mg/kg of rocuronium
Interventions/Control_5 propofol anesthesia + 0.6mg/kg of rocuronium
Interventions/Control_6 propofol anesthesia + 0.9mg/kg of rocuronium
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria ASA1-2, General anesthesia cases
Key exclusion criteria Hepatic or Renal function disorder, BMI>30, history of neuromuscular disease, allergy
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujii Tatsuya
Organization Higashi Ohmiya general hospital
Division name Anesthesiology and Critical care
Zip code
Address 5-18, Higasi Ohmiya, Minuma, Saitama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Higashi Ohmiya general hospital
Division name Anesthesiology and Critical care
Zip code
Address
TEL
Homepage URL
Email stedman.jp@gmail.com

Sponsor
Institute Higasi Ohmiya general hospital
Institute
Department

Funding Source
Organization Higashi Ohmiya general hospital
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
2012 Year 02 Month 14 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 Enrolling by invitation
Date of protocol fixation
2011 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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
2012 Year 02 Month 14 Day
Last modified on
2012 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008591

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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