UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040944 |
|---|---|
| Receipt number | R000046749 |
| Scientific Title | Examination of postoperative nausea and vomiting frequency by using remimazolam |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2020/06/29 13:19:11 |
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Basic information
Public title
Examination of postoperative nausea and vomiting frequency by using remimazolam
Acronym
Examination of postoperative nausea and vomiting frequency by using remimazolam
Scientific Title
Examination of postoperative nausea and vomiting frequency by using remimazolam
Scientific Title:Acronym
Examination of postoperative nausea and vomiting frequency by using remimazolam
Region
| Japan |
Condition
Condition
Breast tumor
Gynecological diseases
Classification by specialty
| Breast surgery | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Remimazolam is an ultra-short acting benzodiazepine general anesthetic approved in January 2020. It is known that volatile inhalation anesthetics which are currently widely used as general anesthetics frequently cause postoperative nausea and vomiting. Postoperative nausea and vomiting have problems such as deterioration of QOL, obstruction of leaving the bed and delay of food intake. This time, we will examine whether postoperative nausea and vomiting are reduced by using remimazolam compared with volatile inhalation anesthetics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Postoperative nausea vomiting
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Female
Key inclusion criteria
Breast tumor
Gynecological diseases
Patients with ASA PS1, 2
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Obata |
Organization
St. Marianna University School
Division name
Dept of Anesthesiology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
y2obata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Obata |
Organization
St. Marianna University School
Division name
Dept of Anesthesiology
Zip code
216-8511
Address
2-16-1 Sugo, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
Homepage URL
y2obata@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School Dept of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School Dept of Anesthesiology
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
St. Marianna University School
Address
2-16-1 2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
Tel
044-977-8111
y2obata@marianna-u.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
| 2020 | Year | 07 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046749
