UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024067 |
|---|---|
| Receipt number | 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 | 2019/09/20 20:01:21 |
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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 | Obstetrics 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
| 1 | 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 | Masaaki |
| Middle name | |
| Last name | Asamoto |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology and Pain Relief Center
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
asamoto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Masaaki |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology and Pain Relief Center
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
asamoto-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3815-5411
todai.masuika@gmail.com
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
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 01 | Day |
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
| 2019 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027675
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
