UMIN-CTR Clinical Trial

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
Last 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
1st 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