UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011133 |
|---|---|
| Receipt number | R000013042 |
| Scientific Title | Development of a novel neurological monitoring during anesthesia |
| Date of disclosure of the study information | 2013/07/08 |
| Last modified on | 2019/02/22 10:30:17 |
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Basic information
Public title
Development of a novel neurological monitoring during anesthesia
Acronym
Neurological monitoring during anesthesia
Scientific Title
Development of a novel neurological monitoring during anesthesia
Scientific Title:Acronym
Neurological monitoring during anesthesia
Region
| Japan |
Condition
Condition
Adult patients undergoing surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop novel neurological monitoring by evaluating perioperative neurological changes
Basic objectives2
Others
Basic objectives -Others
To evaluate perioerative pain or nociceptive responses
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Polygraph signals, vital signs
Key secondary outcomes
Pain, psychological status, postoperative state.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
1 year
Interventions/Control_2
1 year
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing surgery
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Munetaka Hirose |
Organization
Hyogo College of Medicine
Division name
Anesthesiology
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6392
mhirose@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Munetaka Hirose |
Organization
Hyogo College of Medicine
Division name
Anesthesiology
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6392
Homepage URL
mhirose@hyo-med.ac.jp
Sponsor or person
Institute
Deaprtment of Anesthesiology and Pain Medicine, Hyogo College of Medicine
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
| 2013 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Postoperative data
Management information
Registered date
| 2013 | Year | 07 | Month | 06 | Day |
Last modified on
| 2019 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013042
