UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012999
Receipt number R000015175
Scientific Title Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-
Date of disclosure of the study information 2014/01/31
Last modified on 2015/08/03 23:06:42

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Basic information

Public title

Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-

Acronym

Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-

Scientific Title

Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-

Scientific Title:Acronym

Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-

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 compare Fosaprepitant with Ondansetron for prevention of postoperative nausea and vomiting

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

frequency of the postoperative nausea and vimiting

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Fosaprepitant group takes fosaprepitant 150mg div before induction of anesthesia.

Interventions/Control_2

Ondansetron group takes ondansetron 4mg div before induction of anesthesia.

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 the American Society of Anesthesiologists(ASA) physical status 1-2 , who are recieved limb surgery(total knee replacement, total hip replacement)

Key exclusion criteria

Patients are excluded the criteria of the ASA Physical Status of over 3 and taked other antiemetics.
Further,excluded contraindication of fosaprepitant and ondansetron.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eisuke Hamaguchi

Organization

Tokushima University Hospital

Division name

Anesthesiology

Zip code


Address

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

TEL

088-633-7181

Email

hamaguchi@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiusuke Hamaguchi

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

hamaguchi@tokushima-u.ac.jp


Sponsor or person

Institute

Depertment of Anesthesiology, Tokushima Nniversity Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

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 01 Month 31 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

2012 Year 07 Month 31 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 31 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 01 Month 28 Day

Last modified on

2015 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015175


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name