UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007289 |
|---|---|
| Receipt number | 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 15:20:10 |
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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
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
stedman.jp@gmail.com
Sponsor or person
Institute
Higasi Ohmiya general hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008591
