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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022634
Receipt No. 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 2019/02/05

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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
Obsterics 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
Middle name
Last name Hiroyuki Seki
Organization Keio University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjukuku Tokyo, Japan
TEL 03-3353-1211
Email hseki.a3@keio.jp

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

Sponsor
Institute Keio University Hospital
Institute
Department

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
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 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
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 No longer recruiting
Date of protocol fixation
2016 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 26 Day
Last follow-up date
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
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.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


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