UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Kumagai Motoi
Organization	Iwate Medical University Hospital
Division name	Department of Anaesthesiology
Address	19-1, Uchimaru, Morioka, Iwate, Japan
TEL	+81-19-651-5111
Email	bear@kxd.biglobe.ne.jp

Public contact
Name of contact person	Kumagai Motoi
Organization	Iwate Medical University Hospital
Division name	Department of Anaesthesiology
Address	19-1, Uchimaru, Morioka, Iwate, Japan
TEL	+81-19-651-5110(8153)
Homepage URL
Email	bear@kxd.biglobe.ne.jp

Sponsor
Institute	Department of Anaesthesiology, School of Medicine, Iwate Medical University
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019361