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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024067
Receipt No. R000027675
Scientific Title Prospective and Observational Study of Perioperative Physiological Changes in Patients who Underwent General Anesthesia
Date of disclosure of the study information 2016/11/21
Last modified on 2017/09/25

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Basic information
Public title Prospective and Observational Study of Perioperative Physiological Changes in Patients who Underwent General Anesthesia
Acronym Prospective and Observational Study of Perioperative Physiological Changes
Scientific Title Prospective and Observational Study of Perioperative Physiological Changes in Patients who Underwent General Anesthesia
Scientific Title:Acronym Prospective and Observational Study of Perioperative Physiological Changes
Region
Japan

Condition
Condition Patients who underwent surgeries in operating rooms.
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Pediatrics
Ophthalmology Dermatology Oto-rhino-laryngology
Orthopedics Urology Radiology
Anesthesiology Oral surgery Neurosurgery
Cardiovascular surgery Plastic surgery Aesthetic surgery
Operative medicine Emergency medicine Intensive care medicine
Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop a new monitor using Electroencephalogram(EEG).
Basic objectives2 Others
Basic objectives -Others To develop a new monitor which can measure pain and consciousness of patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes EEG, vital data (over 200 patients). The mutual correlation between vital signs or analyzed EEG and surgical invasion or anesthetics.
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
0 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who underwent surgeries in operating rooms.
Key exclusion criteria Surgeries which may affect EEG monitoring such as Head surgery and Neurosurgery.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Asamoto
Organization The University of Tokyo Hospital
Division name Department of Anesthesiology and Pain Relief Center
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email asamoto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Asamoto
Organization The University of Tokyo Hospital
Division name Department of Anesthesiology and Pain Relief Center
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email asamoto-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Nihon Kohden
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational Study

Management information
Registered date
2016 Year 09 Month 15 Day
Last modified on
2017 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027675

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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