UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016685 |
|---|---|
| Receipt number | R000019361 |
| Scientific Title | Effects of sevoflurane vs. propofol on cerebral oxygen saturation measured by near-infrared spectroscopy and jugular venous bulb oxygen saturation during robotic-assisted laparoscopic radical prostatectomy |
| Date of disclosure of the study information | 2015/04/07 |
| Last modified on | 2017/09/02 09:34:03 |
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Basic information
Public title
Effects of sevoflurane vs. propofol on cerebral oxygen saturation measured by near-infrared spectroscopy and jugular venous bulb oxygen saturation during robotic-assisted laparoscopic radical prostatectomy
Acronym
Effects of sevoflurane vs. propofol on cerebral oxygen saturation measured by near-infrared spectroscopy and jugular venous bulb oxygen saturation during robotic-assisted laparoscopic radical prostatectomy
Scientific Title
Effects of sevoflurane vs. propofol on cerebral oxygen saturation measured by near-infrared spectroscopy and jugular venous bulb oxygen saturation during robotic-assisted laparoscopic radical prostatectomy
Scientific Title:Acronym
Effects of sevoflurane vs. propofol on cerebral oxygen saturation measured by near-infrared spectroscopy and jugular venous bulb oxygen saturation during robotic-assisted laparoscopic radical prostatectomy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of different anesthesics which have different effects on cerebral vessels on cerebral oxygenation during robotic-assisted laparoscopic radical prostatectomy.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
jugular venous bulb oxygen saturation
Key secondary outcomes
regional cerebral oxygen saturation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sevoflurane
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
patients undergoing elective robotic-assisted laparoscopic radical prostatectomy at Iwate medical university hospital
Key exclusion criteria
patients with previous episodes of cerebral ischemia or hemorrhage, with serious heart disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kumagai Motoi |
Organization
Iwate Medical University Hospital
Division name
Department of Anaesthesiology
Zip code
Address
19-1, Uchimaru, Morioka, Iwate, Japan
TEL
+81-19-651-5111
bear@kxd.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumagai Motoi |
Organization
Iwate Medical University Hospital
Division name
Department of Anaesthesiology
Zip code
Address
19-1, Uchimaru, Morioka, Iwate, Japan
TEL
+81-19-651-5110(8153)
Homepage URL
bear@kxd.biglobe.ne.jp
Sponsor or person
Institute
Department of Anaesthesiology, School of Medicine, Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anaesthesiology, School of Medicine, Iwate Medical University
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
| 2015 | Year | 04 | Month | 07 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 12 | 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
| 2015 | Year | 03 | Month | 02 | Day |
Last modified on
| 2017 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019361
