UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044666 |
|---|---|
| Receipt number | R000051010 |
| Scientific Title | Comparison of intraoperative circulatory fluctuations between general anesthesia with Remimazolam and general anesthesia with volatile inhalational anesthetics |
| Date of disclosure of the study information | 2021/06/26 |
| Last modified on | 2021/06/26 12:01:46 |
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Basic information
Public title
Comparison of intraoperative circulatory fluctuations between general anesthesia with Remimazolam and general anesthesia with volatile inhalational anesthetics
Acronym
Comparison of intraoperative circulatory fluctuations between general anesthesia with Remimazolam and general anesthesia with volatile inhalational anesthetics
Scientific Title
Comparison of intraoperative circulatory fluctuations between general anesthesia with Remimazolam and general anesthesia with volatile inhalational anesthetics
Scientific Title:Acronym
Comparison of intraoperative circulatory fluctuations between general anesthesia with Remimazolam and general anesthesia with volatile inhalational anesthetics
Region
| Japan |
Condition
Condition
Atrial ventricular arrhythmia
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Remimazolam is an ultra-short-acting benzodiazepine general anesthetic approved in January 2020 and is said to be an anesthetic with little decrease in blood pressure, but there are few reports of its use in ablation treatment in cardiology. .. Ablation in cardiovascular medicine induces tachyarrhythmia during surgery, and PEEP is applied to control breathing, which often causes a decrease in blood pressure, and in many cases, a pressor agent is required during surgery. Volatile inhalational anesthetics, which are currently widely used as general anesthetics, are known to have side effects of cardiac depression, and it is considered that blood pressure decreases frequently during ablation. This time, we will examine whether the use of Remimazolam reduces the decrease in intraoperative blood pressure compared to volatile inhalation anesthetics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduced decrease in blood pressure
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Arrhythmia patients
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Obata |
| Middle name | |
| Last name | Yumi |
Organization
St Marianna university school of medicine
St Marianna university school of mediciney
yokohama city seibu hospital
Division name
Anesthesiology
Zip code
216-8511
Address
Sugao2-16-1 Miyamae Kawasaki Kanagawa
TEL
0449778111
y2obata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Obata |
| Middle name | |
| Last name | Yumi |
Organization
St Marianna university school of medicine St Marianna university school of mediciney yokohama city s
Division name
Anesthesiology
Zip code
216-8511
Address
Sugao2-16-1 Miyamae Kawasaki Kanagawa
TEL
0449778111
Homepage URL
y2obata@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna university school of medicine St Marianna university school of mediciney yokohama city seibu hospital
Institute
Department
Personal name
Funding Source
Organization
St Marianna university school of medicine St Marianna university school of mediciney yokohama city seibu hospital
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 of medicine St Marianna university school of mediciney yokohama city seibu hospital
Address
Sugao2-16-1 Miyamae Kawasaki Kanagawa
Tel
0449778111
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
| 2021 | Year | 06 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 26 | 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
| 2021 | Year | 06 | Month | 26 | Day |
Last modified on
| 2021 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051010
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
