UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030574 |
|---|---|
| Receipt number | R000034342 |
| Scientific Title | Evaluation of pre-medication of olanzapine for post-operative nausea and vomiting in the gynecology surgical patients: a randomized placebo-controlled trial |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2019/05/28 20:24:55 |
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Basic information
Public title
Evaluation of pre-medication of olanzapine for
post-operative nausea and vomiting in the gynecology surgical patients: a randomized placebo-controlled trial
Acronym
Evaluation of pre-medication of olanzapine for post-operative nausea and vomiting in the gynecology surgical patients: a randomized placebo-controlled trial
Scientific Title
Evaluation of pre-medication of olanzapine for
post-operative nausea and vomiting in the gynecology surgical patients: a randomized placebo-controlled trial
Scientific Title:Acronym
Evaluation of pre-medication of olanzapine for post-operative nausea and vomiting in the gynecology surgical patients: a randomized placebo-controlled trial
Region
| Japan |
Condition
Condition
Gynecological surgery patiets
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop the prevention of postoperative nausea and vomiting (PONV). We compare the incidence of PONV in high risk patients using dexamethasone or olanzapine. And we will make clear the efficacy of olanzapine for PONV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The incidence of not PONV after 24 hours after
operation
Key secondary outcomes
The incidence of PONV every hour
The incidence of no nausea and no vomiting every hour
The severity of nausea every hour
The frequency of using anti-emetic agents every hour
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 5mg of olanzapine before 1 hour of admission of operating room
Interventions/Control_2
Administration of placebo before 1 hour of admission of operating room
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
| Not applicable |
Gender
Female
Key inclusion criteria
gynecologic surgical patients
no smoking patients
Key exclusion criteria
the contraindication
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Kawamata |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0610
kawamata@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Kuriyama |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0610
Homepage URL
http://www.wakayama-masui.jp
kuriyama@xa2.so-net.ne.jp
Sponsor or person
Institute
Department of Anesthesiology, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2153
Org. issuing International ID_1
Wakayama Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034342
