UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013908 |
|---|---|
| Receipt number | R000015612 |
| Scientific Title | Safety of olanzapine for the prevention of postoperative nausea and vomiting |
| Date of disclosure of the study information | 2014/05/12 |
| Last modified on | 2014/11/08 15:06:46 |
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Basic information
Public title
Safety of olanzapine for the prevention of postoperative nausea and vomiting
Acronym
Safety of olanzapine
Scientific Title
Safety of olanzapine for the prevention of postoperative nausea and vomiting
Scientific Title:Acronym
Safety of olanzapine
Region
| Japan |
Condition
Condition
gynecological begnin diseases
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm safety of prophylactic use of olanzapine for the prevention of postoperative nausea and vomiting
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
extrapyramidal syndrom, excessive sedation, hyperglycemia, arrythmia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
olanzapine
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients
1) who receive laparoscopic gynecological surgery for benign disease.
2) who are equal to or older than 20 years old.
3) with American Society of Anesthesiologists Physical Status 1 or 2
Key exclusion criteria
Patients
1) who receive epidural anesthesia
2) who were contraindicated to any of the study drugs
3) who have diabetes
4) who take emetogenic or antiemetic drugs within the 24 hours before surgery,
5) who receive emergency surgery
6) who receive open surgery
7) who are pregnant or lactating
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Seki |
Organization
School of Medicine, Keio University
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjukuku Tokyo, Japan
TEL
03-3353-1211
hshiroyukiseki@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Seki |
Organization
School of Medicine, Keio University
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi Shinjukuku, Tokyo Japan
TEL
03-3353-1211
Homepage URL
hshiroyukiseki@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, School of Medicine, Keio University
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
| 2014 | Year | 05 | Month | 12 | 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 | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 08 | Day |
Last modified on
| 2014 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015612
