UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052565 |
|---|---|
| Receipt number | R000059975 |
| Scientific Title | Exploring risk factors for treatment-resistant postoperative nausea and vomiting (PONV): An exploratory prospective observational study |
| Date of disclosure of the study information | 2023/10/20 |
| Last modified on | 2025/04/09 18:45:01 |
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Basic information
Public title
Identification of risk factors for post-operative nausea and vomiting
Acronym
Risk factors for post-operative nausea and vomiting
Scientific Title
Exploring risk factors for treatment-resistant postoperative nausea and vomiting (PONV): An exploratory prospective observational study
Scientific Title:Acronym
Prospective observational study for pre-operative risk factors for post-operative nausea and vomiting
Region
| Japan |
Condition
Condition
All surgical patients receiving general anesthesia
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk factors responsible for PONV occurring beyond our routine preventative approaches.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PONV score within 24hours post-surgery (0:none~4:vomiting)
Key secondary outcomes
1) number of vomit within 24 hours post-surgery
2) number of anti-emetics used within 24 hours post-surgery
3) first time meal after surgery and amount of intake
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving general anesthesia for surgery
Key exclusion criteria
Patients who apply for the following criteria
1) those planned for continued sedation in the intensive care unit
2) those with allergic reaction to either anti-emetics
3) those under steroid treatment pre-operatively planned for steroid cover during anesthesia
4) those determined not-applicable by the responsible personnel
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Natsuko |
| Middle name | |
| Last name | Nozaki-Taguchi |
Organization
Chiba University Hospital/Chiba Cancer Hospital
Division name
Department of Anesthesology and Palliative Care Medicine / Palliative Medicine
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba Japan
TEL
043-222-7171
nn_taguchi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Natsuko |
| Middle name | |
| Last name | Nozaki-Taguchi |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology and Palliative Medicine
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba Japan
TEL
043-222-7171
Homepage URL
nn_taguchi@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana Chuo Chiba Japan
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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 | 10 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Preoperative risk factors and intra-operative drug and other surgery dependent factors will be enrolled for multiple analysis
Management information
Registered date
| 2023 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059975
