UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a novel neurological monitoring during anesthesia
Title of the study (Brief title)	Neurological monitoring during anesthesia
Region	Japan

Condition
Condition	Adult patients undergoing surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop novel neurological monitoring by evaluating perioperative neurological changes
Basic objectives2	Others
Basic objectives -Others	To evaluate perioerative pain or nociceptive responses
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Polygraph signals, vital signs
Key secondary outcomes	Pain, psychological status, postoperative state.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	1 year
Interventions/Control_2	1 year
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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult patients undergoing surgery
Key exclusion criteria	None
Target sample size	100

Research contact person
Name of lead principal investigator	Munetaka Hirose
Organization	Hyogo College of Medicine
Division name	Anesthesiology
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6392
Email	mhirose@hyo-med.ac.jp

Public contact
Name of contact person	Munetaka Hirose
Organization	Hyogo College of Medicine
Division name	Anesthesiology
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6392
Homepage URL
Email	mhirose@hyo-med.ac.jp

Sponsor
Institute	Deaprtment of Anesthesiology and Pain Medicine, Hyogo College of Medicine
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 24 Day
Anticipated trial start date	2013 Year 07 Month 08 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	Postoperative data

Management information
Registered date	2013 Year 07 Month 06 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013042