UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk factors related with postoperative delirium after spine surgery
Title of the study (Brief title)	Risk factors related with postoperative delirium
Region	Japan

Condition
Condition	patients with spine surgery
Classification by specialty	Anesthesiology Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of factors related with postoperative delirium after spine surgery
Basic objectives2	Others
Basic objectives -Others	Comparison of factors related with postoperative delirium after spine surgery
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Analysis of risk foactors in patients with postoperative delirium
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	pstients with spine surgery
Key exclusion criteria	patients with dementia. patients with confusion.
Target sample size	800

Research contact person
Name of lead principal investigator	Noboru Tsukamoto
Organization	Keiyu orthpedic surgery hospital
Division name	Anesthesilogy
Address	1741, hatsuki, tatebayashi, gunma
TEL	0276-72-6000
Email	tsukamoton2@gmail.com

Public contact
Name of contact person	Noboru Tsukamoto
Organization	keiyu orthpedic surgery hospital
Division name	anesthesilogy
Address	1741-, hatsuki, tatebayashi, gunma
TEL	0276-72-6000
Homepage URL
Email	tsukamoton2@gmail.com

Sponsor
Institute	Keiyu orthpedic surgery hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	self founding
Organization
Division
Category of Funding Organization	Self funding
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	慶友整形外科病院（群馬県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 10 Day
Anticipated trial start date	2016 Year 07 Month 01 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	Unpublished
URL releasing results
Results
Other related information	Using CAM analysis sheet, we will identify the patients with postoperative delirium. Then, we will analyze the brisk factor s related to postoperative delirium in patients undergoing spine surgery.

Management information
Registered date	2016 Year 06 Month 20 Day
Last modified on	2016 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026275