UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022634 |
|---|---|
| Receipt number | R000026031 |
| Scientific Title | Effect of Olanzapine on PONV Prophylaxis in Laparoscopic Gynecological Surgery: A Multicenter Randomized Clinical Trial |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2022/09/08 06:03:09 |
* 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
Effect of Olanzapine on PONV Prophylaxis in Laparoscopic Gynecological Surgery: A Multicenter Randomized Clinical Trial
Acronym
Effect of Olanzapine on PONV Prophylaxis in Laparoscopic Gynecological Surgery: A Multicenter Randomized Clinical Trial
Scientific Title
Effect of Olanzapine on PONV Prophylaxis in Laparoscopic Gynecological Surgery: A Multicenter Randomized Clinical Trial
Scientific Title:Acronym
Effect of Olanzapine on PONV Prophylaxis in Laparoscopic Gynecological Surgery: A Multicenter Randomized Clinical Trial
Region
| Japan |
Condition
Condition
benign gynecological disease
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether olanzapine prevents PONV
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The incidence of PONV within 24h after laparoscopic gynecological surgery.
Nausea was defined as a subjective feeling of a desire to vomit without the presence of expulsive muscular movements. Vomiting was defined as the involuntary, forceful expulsion of the contents of stomach. A patient was considered to have PONV if she experienced any episodes of nausea or emesis (vomiting or retching), or if she used rescue antiemetics after tracheal extubation.
Key secondary outcomes
Time to first PONV
Incidence of PONV, emesis, worst VAS score for nausea, incidence of significant nausea (VAS score for nausea equal to or more than 40), use of rescue metoclopramide in the 0-0.5, 0.5-2, 2-6, and 6-24 h after surgery
The VAS score for patient satisfaction regarding nausea
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Oral olanzapine 5 mg 2h prior to anesthesia induction
Interventions/Control_2
Placebo 2h prior to anesthesia indcution
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Patients undergoing laparoscopic gynecological surgery for benign gynecological disease, expected to last at least 1h who are equal to or older than 20 years old and have one or two of the following risk factors for PONV: (1) non-smoking status, (2) a prior history of motion sickness or PONV.
Key exclusion criteria
Patients with diabetes, those who took antiemetic agents within 1 month prior to the surgery and those who take olanzepine, pregnant, parturient and lactating women.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Seki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjukuku Tokyo, Japan
TEL
03-3353-1211
hseki.a3@keio.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Seki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi Shinjukuku, Tokyo Japan
TEL
03-3353-1211
Homepage URL
hseki.a3@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese society of anesthesiologists
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Showa University Hospital
Jikei University School of Medicine Hospital
Nagoya City University Hospital
Kyoto Prefectural Medical University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
keio University School of Medicine, Ethics committee
Address
35 Shinanomachi Shinjuku, Tokyo 160-8582, Japan
Tel
81-3-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | 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
210
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
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 06 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026031
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
