UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021852 |
|---|---|
| Receipt number | R000025198 |
| Scientific Title | Does longer postoperative oxygen administration reduce post-operative nausea and vomiting (PONV) for patients undergoing gynecological laparoscopic surgery? |
| Date of disclosure of the study information | 2016/05/31 |
| Last modified on | 2019/04/11 12:15:41 |
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Basic information
Public title
Does longer postoperative oxygen administration reduce post-operative nausea and vomiting (PONV) for patients undergoing gynecological laparoscopic surgery?
Acronym
Does longer postoperative oxygen administration reduce post-operative nausea and vomiting (PONV) for patients undergoing gynecological laparoscopic surgery?
Scientific Title
Does longer postoperative oxygen administration reduce post-operative nausea and vomiting (PONV) for patients undergoing gynecological laparoscopic surgery?
Scientific Title:Acronym
Does longer postoperative oxygen administration reduce post-operative nausea and vomiting (PONV) for patients undergoing gynecological laparoscopic surgery?
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic gynecological surgery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate if longer postoperative oxygen administration reduces PONV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of PONV incidence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
postoperative oxygen administration 2L/min with nasal cannula for one hour.
Interventions/Control_2
postoperative oxygen administration 2L/min with nasal cannula for five hours.
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
| Not applicable |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Female patient undergoing laparoscopic gynecological surgery
Key exclusion criteria
Patients do not receive total intravenous anesthesia.
Patients whom investigators consider to be ineligible
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKEHIKO NAGAOKA |
Organization
Shin-yurigaoka general hospital
Division name
Anesthesia
Zip code
Address
255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL
0443229991
takeitezzz@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKEHIKO NAGAOKA |
Organization
Shin-yurigaoka General Hospital
Division name
Anesthesia
Zip code
Address
255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL
0443229991
Homepage URL
takeitezzz@gmail.com
Sponsor or person
Institute
Shin-yurigaoka general hospital
Institute
Department
Personal name
Funding Source
Organization
Our institute
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
Address
Tel
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 | 05 | Month | 31 | 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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025198
