UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients
Title of the study (Brief title)	The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients
Region	Japan

Condition
Condition	women who will receive laparoscopic gynecologic surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether Shohangekabukuryouto prevent PONV over 24 hours after laparoscopic gynecologic surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To determine whether Shohangekabukuryouto prevent PONV over 24 hours after laparoscopic gynecologic surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Syouhangekabukuryouto 3g
Interventions/Control_2	lactose 3g
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	60 years-old >=
Gender	Female
Key inclusion criteria	patients over 20 years oldwho will receive laparoscopic gynecologic surgery under general anesthesia at our institution
Key exclusion criteria	Patients who will receive an emergency operation Patients who have allergic reaction to drugs Patients who used prophylactic antiemetic drugs whithin 24 hours before operation Patients who used analgetic drugs whithin 24 hours before operation Patients who have used Chinese harb Patients who is lactose intolerant Patients who we couldn't get a consent form
Target sample size	20

Research contact person
Name of lead principal investigator	Makito Kanako
Organization	Saiseikai central hospital
Division name	Department of Anesthesiology
Address	1-4-17 mita minato-ku Tokyo Japan
TEL	03-3451-8211
Email	canakana87@gmail.com

Public contact
Name of contact person	makito kanako
Organization	Saiseikai Central Hospital
Division name	Department of Anesthesiology
Address	1-4-17 mita minato-ku Tokyo Japan
TEL	03-3451-8211
Homepage URL
Email	canakana87@gmail.com

Sponsor
Institute	Saiseikai Central Hospital
Institute
Department

Funding Source
Organization	Saiseikai Central Hospital Anesthesiology
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 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 21 Day
Anticipated trial start date	2015 Year 08 Month 15 Day
Last follow-up date	2016 Year 11 Month 03 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 11 Month 03 Day
Date analysis concluded	2016 Year 11 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 22 Day
Last modified on	2017 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021283