UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A recent survey of postoperative nausea and vomiting
Title of the study (Brief title)	A recent survey of postoperative nausea and vomiting
Region	Japan

Condition
Condition	Patients undergone operation
Classification by specialty	Anesthesiology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Prospective study of incidence of PONV
Basic objectives2	Others
Basic objectives -Others	Prospective study of risk factors for PONV
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of PONV in 24hr after operation
Key secondary outcomes	The risk factors for PONV

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	0 days-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Every postoperative patient who have undergone a surgical procedure under anesthetic management by a anesthesiologist
Key exclusion criteria	Patients postoperatively managed with artificial ventilation, patients maintained with more than 2 kinds of anesthetic, patients underwent electricconvulsive therapy
Target sample size	1000

Research contact person
Name of lead principal investigator	Maiko HOSHIKA
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Anesthesiology and Intensive Care Medicine
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL	052-851-5511
Email	myconjar@yahoo.co.jp

Public contact
Name of contact person	Maiko HOSHIKA
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Anesthesiology and Intensive Care Medicine
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL	052-851-5511
Homepage URL
Email	myconjar@yahoo.co.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya city east medical center, Kainan hospital, Okazaki city hospital
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	名古屋市東部医療センター（愛知県）、JA厚生連海南病院（愛知県）、岡崎市民病院（愛知県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 08 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 06 Month 08 Day
Anticipated trial start date	2015 Year 06 Month 08 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 06 Month 16 Day
Date trial data considered complete	2016 Year 07 Month 09 Day
Date analysis concluded	2016 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study, Incidence of PONV and Risk for PONV, over 1000 cases

Management information
Registered date	2015 Year 06 Month 04 Day
Last modified on	2016 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020573