UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016923 |
|---|---|
| Receipt number | R000019642 |
| Scientific Title | Study for perioperative management and the safety |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2017/09/28 00:04:24 |
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Basic information
Public title
Study for perioperative management and the safety
Acronym
perioperative safe study
Scientific Title
Study for perioperative management and the safety
Scientific Title:Acronym
perioperative safe study
Region
| Japan |
Condition
Condition
All patients undergone any surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate effective and optimal perioperative anesthetic management by comparing sedation status, analgesics and various monitoring.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vital signs, pain score and patients satisfaction
Key secondary outcomes
cpmplication
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who undergone surgery
Key exclusion criteria
Patients who cannot permit to include this study
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Yamauchi |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
Address
Seiryo-cho 1-1, Aoba-ku, Sendai, Japan
TEL
022-717-7321
yamauchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Yamauchi |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
Address
Seiryo-cho 1-1, Aoba-ku, Sendai, Japan
TEL
022-717-7321
Homepage URL
yamauchi@med.tohoku.ac.jp
Sponsor or person
Institute
Masanori Yamauchi
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate perioperative status, especially evaluate usefulness of new monitors or new anesthesia-related drugs.
Management information
Registered date
| 2015 | Year | 03 | Month | 26 | Day |
Last modified on
| 2017 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019642
