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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044442
Receipt No. R000050771
Scientific Title Comparison of postoperative nausea and vomiting with remimazolam and propofol
Date of disclosure of the study information 2021/06/05
Last modified on 2021/06/05

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Basic information
Public title Comparison of postoperative nausea and vomiting with remimazolam and propofol
Acronym Comparison of postoperative nausea and vomiting with remimazolam and propofol
Scientific Title Comparison of postoperative nausea and vomiting with remimazolam and propofol
Scientific Title:Acronym Comparison of postoperative nausea and vomiting with remimazolam and propofol
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Remimazolam besylate was approved as a general anesthetic in Japan in August 2020, and we started using it at our hospital in November. It is thought to have less circulatory depression and vascular pain than the conventionally used propofol. However, the exact incidence of postoperative nausea and vomiting as complications is unknown.We will examine the incidence of side effects, mainly postoperative nausea and vomiting, in patients using remimazolam besylate and propofol.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of postoperative nausea and vomiting from immediately after surgery to the second postoperative day.
Key secondary outcomes Comparison of vascular pain, circulatory depression (bradycardia, hypotension), intraoperative arousal, and postoperative complications (respiratory depression, delayed arousal, delirium, shivering, erythema and headache).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Remimazolam group.
Interventions/Control_2 Propofol group.
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

Not applicable
Gender Female
Key inclusion criteria Female patients over 20 years of age undergoing unilateral mastectomy.
Ability to obtain informed consent.
ASA classification 1 or 2.
Key exclusion criteria Contraindication to application of both remimazolam besylate and propofol.
Contraindication to regional anesthesia.
BMI higher than 35 kg/m2.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Chie
Middle name
Last name Hirose
Organization Suwa Red-Cross Hospital
Division name Anesthesiology
Zip code 3928510
Address 5-11-50, Kogan Dori, Suwa City, Nagano Prefecture
TEL 0266576062
Email chirose@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Chie
Middle name
Last name Hirose
Organization Suwa Red-Cross Hospital
Division name Anesthesiology
Zip code 3928510
Address 5-11-50, Kogan Dori, Suwa City, Nagano Prefecture
TEL 0266576062
Homepage URL
Email chirose@shinshu-u.ac.jp

Sponsor
Institute Suwa Red-Cross Hospital
Institute
Department

Funding Source
Organization Non
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 Suwa Red-Cross Hospital
Address 5-11-50, Kogan Dori, Suwa City, Nagano Prefecture
Tel 0266526111
Email chirose@shinshu-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
2021 Year 06 Month 05 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 Enrolling by invitation
Date of protocol fixation
2021 Year 05 Month 28 Day
Date of IRB
2021 Year 05 Month 28 Day
Anticipated trial start date
2021 Year 05 Month 28 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 05 Day
Last modified on
2021 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050771

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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