UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevention of Postoperative Nausea and Vomiting by Olanzapine (A Preliminary Study)
Title of the study (Brief title)	Prevention of Postoperative Nausea and Vomiting by Olanzapine (A Preliminary Study)
Region	Japan

Condition
Condition	Benign gynecological diseases
Classification by specialty	Obsterics 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	Hiroshi Morisaki
Organization	Keio University School of Medicine
Division name	Anesthesiology
Address	35 Shinanomachi, Shinjukuku Tokyo, Japan
TEL	03-3353-1211
Email	morisaki@z8.keio.jp

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

Sponsor
Institute	Department of Anesthesiology, Keio University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019248