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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000019962
Receipt No. R000023048
Scientific Title The efficacy of serotonin 5HT3 receptor antagonist Granisetron for surgical patients who have postoperative nausea and vomiting
Date of disclosure of the study information 2015/11/27
Last modified on 2015/11/30

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Basic information
Public title The efficacy of serotonin 5HT3 receptor antagonist Granisetron for surgical patients who have postoperative nausea and vomiting
Acronym The efficacy of the granisetron for PONV
Scientific Title The efficacy of serotonin 5HT3 receptor antagonist Granisetron for surgical patients who have postoperative nausea and vomiting
Scientific Title:Acronym The efficacy of the granisetron for PONV
Region
Japan

Condition
Condition Post laparoscopic cholecystectomy
Post laparoscopic ovarian cystectomy
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reserch the efficacy of serotonin 5HT3 receptor antagonist Granisetron (1mg) for post operative nausea and vomiting
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes evaluation of nausea and vomiting using visual analog scale (VAS) 30 minutes after surgery
(VAS:scoring from 0 to 10)
Key secondary outcomes If the VAS is bigger than 3, Granisetoron or Metoclopramide are given.
If the VAS is bigger than 3 after administrating Metoclopramide, Granisetron is given.

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Visual Analog Scale
(Scale from 0 to 10)
Interventions/Control_2 Granisetron 30 minutes after the end of surgery
Interventions/Control_3 Metoclopramide 30 minutes after the end of surgery
Interventions/Control_4 Granisetron during surgery for the prevention of PONV
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 Male and Female
Key inclusion criteria Healthy patients who are scheduled the electice surgery

Patients who have consented for this study
Key exclusion criteria Patients who have not consented for this study

Patients who cannot evaluate postoperative nausea and vomiting
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Watanabe
Organization Yotsuya Medical Cube
Division name Dept Pharmacy
Zip code
Address Nibancho 7-7 Chiyoda-Ku Tokyo
TEL 03-3261-0401
Email watanabe@mcube.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Watanabe
Organization Yotsuya Medical Cube
Division name Dept Pharmacy
Zip code
Address Nibancho 7-7 Chiyoda-Ku Tokyo
TEL 03-3261-0401
Homepage URL
Email watanabe@mcube.jp

Sponsor
Institute Yotsuya Medical Cube
Institute
Department

Funding Source
Organization None
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 四谷メディカルキューブ

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 27 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 Suspended
Date of protocol fixation
2014 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 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
2015 Year 11 Month 27 Day
Last modified on
2015 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023048

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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