UMIN-CTR Clinical Trial

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