UMIN-CTR Clinical Trial

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 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
Email	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
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	keio University School of Medicine, Ethics committee
Address	35 Shinanomachi Shinjuku, Tokyo 160-8582, Japan
Tel	81-3-3353-1211
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026031