UMIN-CTR Clinical Trial

Basic information
Public title	Depth prediction of spinal anesthesia using preoperative CT
Acronym	Preoperative CT and spinal anesthesia
Scientific Title	Depth prediction of spinal anesthesia using preoperative CT
Scientific Title:Acronym	Preoperative CT and spinal anesthesia
Region	Japan

Condition
Condition	Transurethral resection of bladder tumor or transurethral resection of prostate
Classification by specialty	Urology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Correlation between depth of spinal anesthesia and depth measured in preoperative Computed tomography
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Depth of spinal anesthesia
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who undergo transurethral resection of bladder tumor or prostate under spinal anesthesia
Key exclusion criteria	Patients without CT images taken within 6 months before surgery
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Junko Middle name Last name Nakahira
Organization	Osaka Medical College
Division name	Department of Anesthesiology
Zip code	569-8686
Address	Daigaku-machi 2-7, Takatsuki, Osaka, Japan
TEL	072-683-1221
Email	ane052@osaka-med.ac.jp

Public contact
Name of contact person	1st name Junko Middle name Last name Nakahira
Organization	Osaka Medical College
Division name	Department of Anesthesiology
Zip code	569-8686
Address	Daigaku-machi 2-7, nTAKATSUKI, Osaka
TEL	+81726831221
Homepage URL
Email	ane052@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
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	Ethics Committee, Osaka Medical College
Address	2-7 DAIGAKU-MACHI
Tel	+81726831221
Email	rinri@osaka-med.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	大阪医科大学（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 06 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	68
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	2017 Year 11 Month 06 Day
Date of IRB	2017 Year 11 Month 07 Day
Anticipated trial start date	2017 Year 11 Month 08 Day
Last follow-up date	2020 Year 01 Month 28 Day
Date of closure to data entry	2020 Year 01 Month 28 Day
Date trial data considered complete	2020 Year 01 Month 28 Day
Date analysis concluded	2020 Year 01 Month 28 Day

Other
Other related information	We are preparing the manuscript.

Management information
Registered date	2017 Year 09 Month 07 Day
Last modified on	2020 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033216