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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012365
Receipt No. 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

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

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
URL(English) https://upload.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


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