UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of perioperative nociceptive response
Title of the study (Brief title)	The study of nociceptive response
Region	Japan

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

Objectives
Narrative objectives1	To develop a monitor for perioperative nociceptive responses
Basic objectives2	Others
Basic objectives -Others	To monitor perioperative nociceptive responses
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Perioperative nociceptive responses
Key secondary outcomes	Perioperative morbidity and postoperative pain

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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	Dept Anesthesiology and Pain Med
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
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	Dept Anesthesiology and Pain Med
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6392
Homepage URL
Email	mhirose@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
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 06 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 05 Day
Anticipated trial start date	2017 Year 06 Month 05 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	Perioperative nociceptive responses

Management information
Registered date	2017 Year 06 Month 19 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=R000031879