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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030574
Receipt No. 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

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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
Email 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
Email kuriyama@xa2.so-net.ne.jp

Sponsor
Institute Department of Anesthesiology, Wakayama Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034342

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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