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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016710
Receipt No. R000019248
Scientific Title Prevention of Postoperative Nausea and Vomiting by Olanzapine (A Preliminary Study)
Date of disclosure of the study information 2015/03/09
Last modified on 2016/12/16

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Basic information
Public title Prevention of Postoperative Nausea and Vomiting by Olanzapine (A Preliminary Study)
Acronym Prevention of Postoperative Nausea and Vomiting by Olanzapine (A Preliminary Study)
Scientific Title Prevention of Postoperative Nausea and Vomiting by Olanzapine (A Preliminary Study)
Scientific Title:Acronym Prevention of Postoperative Nausea and Vomiting by Olanzapine (A Preliminary Study)
Region
Japan

Condition
Condition Benign gynecological diseases
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine when is the best timing to give olanzapine for PONV prophylaxis in patients undergoing laparoscopic gynecological surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of PONV during 24h after surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Oral olanzapine 10 mg (taken 9 p.m. on the day before the surgery)
Interventions/Control_2 Oral olanzapine (10 mg taken 9 p.m. on the day before the surgery and 5 mg taken when leaving the ward on the day of the surgery)
Interventions/Control_3 Oral olanzapine 10 mg (taken 4h before leaving the ward on the day of the surgery)
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

Not applicable
Gender Female
Key inclusion criteria Patients who are American Society for Anesthesiologists (ASA) Physical Status I or II
Key exclusion criteria Patients who
1) receive or are expected to receive epidural anesthesia
2) are contraindication to the use of any of the study medications
3) have diabetes
4) took antiemetics within 24h prior to the surgery
5) Emergency surgery
6) receive open surgery
7) are pregnant or lactating
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Morisaki
Organization Keio University School of Medicine
Division name Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjukuku Tokyo, Japan
TEL 03-3353-1211
Email morisaki@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Seki
Organization Keio University School of Medicine
Division name Anesthesiology
Zip code
Address 35 Shinanomachi Shinjukuku, Tokyo Japan
TEL 03-3353-1211
Homepage URL
Email hseki@a3.keio.jp

Sponsor
Institute Department of Anesthesiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, Keio University School of Medicine
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
Email

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 03 Month 09 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
2014 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 17 Day
Last follow-up date
Date of closure to data entry
2015 Year 08 Month 01 Day
Date trial data considered complete
2015 Year 08 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 04 Day
Last modified on
2016 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019248

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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