UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014432 |
|---|---|
| Receipt number | R000016790 |
| Scientific Title | Effect of dexmedetomidine infusion on the intraocular pressure during Robotic Radical Prostatectomy |
| Date of disclosure of the study information | 2014/06/30 |
| Last modified on | 2019/07/08 15:49:49 |
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Basic information
Public title
Effect of dexmedetomidine infusion on the intraocular pressure during Robotic Radical Prostatectomy
Acronym
Effect of dexmedetomidine infusion on the intraocular pressure during Robotic Radical Prostatectomy
Scientific Title
Effect of dexmedetomidine infusion on the intraocular pressure during Robotic Radical Prostatectomy
Scientific Title:Acronym
Effect of dexmedetomidine infusion on the intraocular pressure during Robotic Radical Prostatectomy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
investigating whether dexmedetomidine could reduce intraocular pressure during RALP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraocular pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dexmedetomidine 0.4mcg/kg/hr
Interventions/Control_2
placebo
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
patients undergoing elective Robotic Radical Prostatectomy under general anesthesia at Ehime University Hospital
Key exclusion criteria
history of drug allergy to dexmedetomidine,glaucoma,Patient with a history of eye surgery,Patient who have receiving any medication known to alter IOP,BMI over35
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | KItamura |
Organization
Ehime University Hospital
Division name
Department of Anesthesiology
Zip code
7910295
Address
shitukawa,toon city,Ehime
TEL
089-964-5111
kitamura.sakiko.mh@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Kitamura |
Organization
Ehime Uniersity Hospital
Division name
Department of Anesthesioloty
Zip code
791-0295
Address
shitukawa,toon city,Ehime
TEL
089-964-5111
Homepage URL
kitamura.sakiko.mh@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University School of Medicine,Departmet of Anesthesioloty
Institute
Department
Personal name
Funding Source
Organization
Ehime University School of Medicine,Department of Anesthesioloty
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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.ac.jp
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
| 2014 | Year | 06 | Month | 30 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 30 | Day |
Last modified on
| 2019 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016790
