UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051952 |
|---|---|
| Receipt number | R000059289 |
| Scientific Title | Postoperative Nausea and Vomiting and Duration of Smoking Cessation: a retrospective observational study. |
| Date of disclosure of the study information | 2023/08/20 |
| Last modified on | 2024/04/20 11:54:17 |
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Basic information
Public title
Postoperative Nausea and Vomiting and Duration of Smoking Cessation: a retrospective observational study.
Acronym
PONVSC
Scientific Title
Postoperative Nausea and Vomiting and Duration of Smoking Cessation: a retrospective observational study.
Scientific Title:Acronym
PONVSC
Region
| Japan |
Condition
Condition
Postoperative patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the occurrence of PONV and the duration of smoking cessation.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between the occurrence of PONV and the brinkman index.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For patients with a past smoking habit, evaluate the risk of developing PONV for the duration of the smoking cessation period using multivariate analysis.
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
Male and Female
Key inclusion criteria
Patients 20 years of age or older who underwent surgery under general anesthesia after August 2022 and before June 2023 and who are current or ex-smokers.
Key exclusion criteria
Pre-operative or post-operative outpatient records are missing.
Emergency surgery.
Dementia.
Mental retardation.
Target sample size
667
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1342
masui@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1342
Homepage URL
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fukushima Medical University
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
Tel
0245471825
rs@fmu.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 | 08 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following previously obtained medical information should be collected from the medical record
(1) age, sex, diagnosis, surgical procedure, and surgical department
(2) Smoking habits, susceptibility to motion sickness, history of PONV
(3) method of anesthesia, duration of anesthesia, intraoperative use of antiemetics, postoperative use of opioids
(4) presence or absence of nausea and vomiting, duration of postoperative pain
Management information
Registered date
| 2023 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059289
| 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 |
