UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015318
Receipt number R000016903
Scientific Title SubstanceP and postoperative nausea and vimiting
Date of disclosure of the study information 2014/10/02
Last modified on 2016/10/18 19:04:22

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Basic information

Public title

SubstanceP and postoperative nausea and vimiting

Acronym

SubstanceP and postoperative nausea and vimiting

Scientific Title

SubstanceP and postoperative nausea and vimiting

Scientific Title:Acronym

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

1st name
Middle name
Last name Yasuo Tsutsumi

Organization

Tokushima University Hospital

Division name

Anesthesiology

Zip code


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

1st name
Middle name
Last name Nami Kakuta

Organization

Tokushima University Hospital

Division name

Anesthesiology

Zip code


Address

Kuramoto 3-18-15, Tokushima 770-8503, Japan

TEL

088-633-7181

Homepage URL


Email

kakuta.nami@tokushima-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Tokushima University Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Completed

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016903


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name