UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018532 |
|---|---|
| Receipt number | R000021445 |
| Scientific Title | Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting in oral and maxillofacial surgery |
| Date of disclosure of the study information | 2015/10/10 |
| Last modified on | 2016/03/25 16:23:03 |
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Basic information
Public title
Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting in oral and maxillofacial surgery
Acronym
Fosaprepitant versus Ondansetron for prevention of PONV
Scientific Title
Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting in oral and maxillofacial surgery
Scientific Title:Acronym
Fosaprepitant versus Ondansetron for prevention of PONV
Region
| Japan |
Condition
Condition
postoperative nausea and vomiting
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare Fosaprepitant with Ondansetron for prevention of postoperative nausea and vomiting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of the postoperative vomiting/nausea.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Fosaprepiitant group takes fosaprepitant 150mg div before induction os anesthesia.
Interventions/Control_2
Ondansetron group takes ondansetron 4mg div before induction os anesthesia.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible patients meet the criteria of the ASA PS 1-3, who are received oral surgery.
Key exclusion criteria
ASA PS over IV.
Take other antiemetics.
Containdication to fosaprepitant or ondansetron.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Tsutsumi |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
Address
3-18-15 Kurtamoto Tokushima
TEL
088-633-7181
tsutsumi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Tsutsumi |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
Address
3-18-15 Kurtamoto Tokushima
TEL
088-633-7181
Homepage URL
tsutsumi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
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
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
| 2015 | Year | 10 | Month | 10 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 10 | 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
| 2015 | Year | 08 | Month | 03 | Day |
Last modified on
| 2016 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021445
