UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change of cerebral regional oxygen saturation using near-infrared spectroscopy at spinal anesthesia and at dexmedetomidine or propofol administration
Title of the study (Brief title)	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	Tadahiko Ishiyama
Organization	University of Yamanashi, Faculty of Medicine, University of Yamanashi Hospital
Division name	Surgical Center
Address	1110 Shimokato, Chuo, Yamanashi
TEL	055-273-1111
Email	ishiyama@yamanashi.ac.jp

Public contact
Name of contact person	Tadahiko Ishiyama
Organization	University of Yamanashi, Faculty of Medicine, University of Yamanashi Hospital
Division name	Surgical Center
Address	1110 Shimokato, Chuo, Yamanashi
TEL	055-273-1111
Homepage URL
Email	ishiyama@yamanashi.ac.jp

Sponsor
Institute	University of Yamanashi
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030125