UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041151 |
|---|---|
| Receipt number | R000046998 |
| Scientific Title | Quantitative estimation of nociception during general anesthesia using multiple non-invasive parameters |
| Date of disclosure of the study information | 2020/07/27 |
| Last modified on | 2023/07/24 15:52:41 |
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Basic information
Public title
Prediction of the degree of painful sensation during general anesthesia
Acronym
Prediction of the degree of pain during general anesthesia
Scientific Title
Quantitative estimation of nociception during general anesthesia using multiple non-invasive parameters
Scientific Title:Acronym
Quantitative measurement of nociception during general anesthesia
Region
| Japan |
Condition
Condition
Major abdominal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Observation of trends of heart rate, plethysmographic waveform, oxygen consumption, carbon dioxide production triggered by the typical nociception during general anesthesia
Basic objectives2
Others
Basic objectives -Others
Development of novel diagnostic indices
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
trends of heart rate, plethysmographic waveform, oxygen consumption, carbon dioxide production triggered by incision
Key secondary outcomes
(1) trends of heart rate, plethysmographic waveform, oxygen consumption, carbon dioxide production triggered by tracheal intubation
(2) trends of heart rate, plethysmographic waveform, oxygen consumption, carbon dioxide production triggered by nasogastric tube insertion
(3) trends of heart rate, plethysmographic waveform, oxygen consumption, carbon dioxide production triggered by tracheal tube removal
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective major non-cardiac surgery
Patients who require tracheal intubation and nasogastric tube insertion
Key exclusion criteria
Presence of arrythmia or treatment with pacemaker
Contraindication of pulse contour cardiac output monitoring
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
ykotake@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Toho University Ohashi Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional review board, Toho University Ohashi Medical Center
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
Tel
03-3468-1251
ohashi.rinri@ext.toho-u.ac.jp
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
東邦大学医療センター大橋病院（東京都）
Toho University Ohashi Medical Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
(1) Blood volume estimation by passive leg raising and ultrasonographic determination of inferior vena cava.
(2) Heart rate variability analysis using maximal entropy method
(3) Plethysgographic wave amplitude
(4) Oxygen consumption and carbod dioxide production with indirect calorimetry
(5) Temporal trend of aforementioned parameters during tracheal intubation, nasogastric tube insertion, incision and tracheal tube removal
Management information
Registered date
| 2020 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046998
| Research Plan | |
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| 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 |
