UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	SubstanceP and postoperative nausea and vimiting
Title of the study (Brief title)	SubstanceP and postoperative nausea and vimiting
Region	Japan

Condition
Condition	postoperative nausea and vomiting
Classification by specialty	Anesthesiology Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigated the relationship between postoperative nausea and vomiting(PONV) and substanceP.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Episodes of nausea and vomiting
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Maneuver Other
Interventions/Control_1	We measured plasma levels of substanceP on the day before operation, intraoperative pediod and postoperative period.
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Eligible patients meet the criteria of American Society of Anesthesiologists(ASA)physical status of I-II.
Key exclusion criteria	Patients are excluded the criteria of American Society of Anesthesiologists(ASA)physical status of over III.
Target sample size	30

Research contact person
Name of lead principal investigator	Yasuo Tsutsumi
Organization	Tokushima University Hospital
Division name	Anesthesiology
Address	Kuramoto 3-18-15, Tokushima 770-8503, Japan
TEL	088-633-7181
Email	tsutsumi@tokushima-u.ac.jp

Public contact
Name of contact person	Nami Kakuta
Organization	Tokushima University Hospital
Division name	Anesthesiology
Address	Kuramoto 3-18-15, Tokushima 770-8503, Japan
TEL	088-633-7181
Homepage URL
Email	kakuta.nami@tokushima-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Tokushima University Hospital
Institute
Department

Funding Source
Organization	Tokushima University Hospital
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	2014 Year 10 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 10 Month 02 Day
Last modified on	2016 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016903