UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016710 |
|---|---|
| Receipt number | 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 21:04:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
hseki@a3.keio.jp
Sponsor or person
Institute
Department of Anesthesiology, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019248
