UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044442 |
|---|---|
| Receipt number | 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 10:45:52 |
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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
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
chirose@shinshu-u.ac.jp
Sponsor or person
Institute
Suwa Red-Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050771
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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