UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	y2obata@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School Dept of Anesthesiology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046749