UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026225 |
|---|---|
| Receipt number | R000030125 |
| Scientific Title | Change of cerebral regional oxygen saturation using near-infrared spectroscopy at spinal anesthesia and at dexmedetomidine or propofol administration |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2018/02/21 14:45:30 |
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Basic information
Public title
Change of cerebral regional oxygen saturation using near-infrared spectroscopy at spinal anesthesia and at dexmedetomidine or propofol administration
Acronym
Change of cerebral regional oxygen saturation at spinal anesthesia and at dexmedetomidine or propofol administration
Scientific Title
Change of cerebral regional oxygen saturation using near-infrared spectroscopy at spinal anesthesia and at dexmedetomidine or propofol administration
Scientific Title:Acronym
Change of cerebral regional oxygen saturation at spinal anesthesia and at dexmedetomidine or propofol administration
Region
| Japan |
Condition
Condition
Bladder tumor
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change of cerebral regional tissue oxygen saturation values during dexmedetonidine sedation or propofol sedation under spinal anesthesia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebral regional tissue oxygen saturation values during dexmedetonidine sedation or propofol sedation under spinal anesthesia.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dexmedetomidine
Interventions/Control_2
Propofol
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo elective transurethral resection of bladder tumor under spinal anesthesia combined with sedation using dexmedetomidine or propofol.
Key exclusion criteria
Patients with cerebral diseases.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadahiko Ishiyama |
Organization
University of Yamanashi, Faculty of Medicine, University of Yamanashi Hospital
Division name
Surgical Center
Zip code
Address
1110 Shimokato, Chuo, Yamanashi
TEL
055-273-1111
ishiyama@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadahiko Ishiyama |
Organization
University of Yamanashi, Faculty of Medicine, University of Yamanashi Hospital
Division name
Surgical Center
Zip code
Address
1110 Shimokato, Chuo, Yamanashi
TEL
055-273-1111
Homepage URL
ishiyama@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
University of Yamanashi
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030125
