UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050576 |
|---|---|
| Receipt number | R000057598 |
| Scientific Title | Research of neural correlates underlying postoperative nausea and vomiting |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/03/16 09:52:32 |
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Basic information
Public title
Investigation of neural correlates causing postoperative nausea and vomiting
Acronym
Neural correlates underlying postoperative nausea and vomiting
Scientific Title
Research of neural correlates underlying postoperative nausea and vomiting
Scientific Title:Acronym
Neural correlates underlying postoperative nausea and vomiting
Region
| Japan |
Condition
Condition
Postoperative nausea and vomiting
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For development of tailor-made PONV prevention methods, our aim is investigation of neural correlates underlying postoperative nausea and vomiting.
Basic objectives2
Others
Basic objectives -Others
By using noninvasive neuroimaging methods, we investigate neural correlates predicting onset of postoperative nausea and vomiting.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neural structure and function predicting PONV onset.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) 20 years old or older
2) Patients undergoing planned total hysterectomy with general anesthesia
Key exclusion criteria
1) Patients having serious systemic complications
2) Patients having severe mental illness
3) Patients with nyctophobia or claustrophobia
4) Patients having implanted metal
5) Pregnant patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kawamichi |
Organization
Gunma university graduate school of medicine
Division name
Department of anesthesiology
Zip code
371-8511
Address
Showa-machi 3-39-22, Maebashi, Gunma
TEL
027-220-7111
hiroaki.kawamichi@gmail.com
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kawamichi |
Organization
Gunma university graduate school of medicine
Division name
Department of anesthesiology
Zip code
371-8511
Address
Showa-machi 3-39-22, Maebashi, Gunma
TEL
027-220-7111
Homepage URL
hiroaki.kawamichi@gmail.com
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Hiroaki Kawamichi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
Showa-machi 3-39-22, Maebashi, Gunma
Tel
027-220-8740
gunmaciru-office@umin.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
structural and functional neuroimaging data of patients before and after surgery
Management information
Registered date
| 2023 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057598
