UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012365
Receipt number R000014454
Scientific Title Preventing postoperative nausea and vomiting, effect of dexametasone
Date of disclosure of the study information 2013/12/01
Last modified on 2020/05/16 11:48:20

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Basic information

Public title

Preventing postoperative nausea and vomiting, effect of dexametasone

Acronym

Preventing postoperative nausea and vomiting , effect of dexametasone

Scientific Title

Preventing postoperative nausea and vomiting, effect of dexametasone

Scientific Title:Acronym

Preventing postoperative nausea and vomiting , effect of dexametasone

Region

Japan


Condition

Condition

postoperative nausea and vomiting

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

preventing postoperative nausea and vomiting

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

incidence of PONV

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

dexametasone and saline

Interventions/Control_2

saline alone

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

70 years-old >

Gender

Female

Key inclusion criteria

Patient of breast cancer

Key exclusion criteria

patients with a history of drug allergy,
diabetes control was unfavorable,
dexamethasone was contraindicated,
patients received opioids before surgery,
patients underwent autologous breast reconstruction.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Masako
Middle name
Last name Sakuragi

Organization

Jichi Medical University

Division name

breast surgery

Zip code

329-0498

Address

Yakushiji 3311-1, Simotsuke city, Tochigi prefecture, Japan

TEL

0285-44-2111

Email

masako@omiya.jichi.ac.jp


Public contact

Name of contact person

1st name Masako
Middle name
Last name Sakuragi

Organization

Jichi medical university

Division name

breast surgery

Zip code

329-0498

Address

Yakushiji 3311-1, Simotsuke city, Tochigi prefecture, Japan

TEL

0285-44-2111

Homepage URL


Email

masako@omiya.jichi.ac.jp


Sponsor or person

Institute

Jichi medical university, department of breast surgery, department of Anesthegiology

Institute

Department

Personal name



Funding Source

Organization

none

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

Jichi Medical University

Address

3311-1, Yakushiji, Shimotsuke city, Tochigi, Japan

Tel

0285-44-2111

Email

masako@omiya.jichi.ac.jp


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

2013 Year 12 Month 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000014454

Publication of results

Partially published


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000014454

Number of participants that the trial has enrolled

208

Results

Informed consent was obtained from 208 patients between December 2013 and August 2015. Thirteen patients who withdrew from this study, 23 in whom the contents of anesthesia were changed, and 2 who underwent additional surgery due to postoperative hemorrhage were excluded from analysis. Finally, 170 patients (Group D: 85, Group S: 85) were analyzed. PONV was observed in 27 patients (31.7%) in Group D and in 26 (30.6%) in Group S. There was no significant difference between the two groups (p=0.868).

Results date posted

2020 Year 05 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The subjects were primary breast cancer patients, aged 20 to 69 years, who underwent surgery in our hospital.

Participant flow

After informed consent was obtained, the patients were assigned to receive dexamethasone (Group D) or physiological saline (Group S) through randomization with the table of random numbers.

Adverse events

No patients had any adverse events.

Outcome measures

The presence or absence of PONV within 48 hours after surgery was established.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 12 Month 01 Day

Date of IRB

2013 Year 12 Month 01 Day

Anticipated trial start date

2013 Year 12 Month 05 Day

Last follow-up date

2017 Year 05 Month 30 Day

Date of closure to data entry

2017 Year 05 Month 30 Day

Date trial data considered complete

2017 Year 10 Month 31 Day

Date analysis concluded

2017 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 11 Month 20 Day

Last modified on

2020 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014454


Research Plan
Registered date File name
2020/05/16 PONVプロトコール最終提出分.doc

Research case data specifications
Registered date File name
2020/05/16 症状経過票②.doc

Research case data
Registered date File name
2020/05/16 PONV試験解析結果公開.xlsx