UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045628 |
|---|---|
| Receipt number | R000050360 |
| Scientific Title | Effects of Remimazolam and Propofol on Blood Pressure in Patients Undergoing TAVI under General Anesthesia |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/10/26 07:56:32 |
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Basic information
Public title
Effects of Remimazolam and Propofol on Blood Pressure in Patients Undergoing TAVI under General Anesthesia
Acronym
TIVA study in TAVI patients
Scientific Title
Effects of Remimazolam and Propofol on Blood Pressure in Patients Undergoing TAVI under General Anesthesia
Scientific Title:Acronym
TIVA study in TAVI patients
Region
| Japan |
Condition
Condition
Aortic Valve Stenosis
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In general anesthesia of patients undergoing transcatheter Aortic Valve Implantation (TAVI) for severe aortic valve stenosis, the intravenous anesthetic Remimazolam is used to prevent hypotension at the time of induction of anesthesia. Verify if it can be done.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of hypotensive time from the start of anesthesia induction to the start of surgery
Key secondary outcomes
Time integral value of blood pressure decrease period at anesthesia induction time
Presence or absence of hypertension at the time of induction of anesthesia
Rate of change in cardiac output and peripheral vascular resistance during anesthesia induction time
Amount of pressor agent used during anesthesia induction time
Presence or absence of delirium in the intensive care unit after surgery
Length of stay in the intensive care unit after surgery
Death 30 days after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
remimazolam used
Interventions/Control_2
propofol used
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing TAVI under general anesthesia
Key exclusion criteria
Patients who cannot speak daily in Japanese
Patients who do not understand the explanation of the research content
Patients with atrial fibrillation upon entering the operating room
Patients with contraindications to using Remimazolam
Patients contraindicated for propofol use
Patients with acute mental illness
Patients who have been offered to withdraw their consent after registration
Patients who died during the operation
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Kotani |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348522
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744223051
tk19830715@gmail.com
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Kotani |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348522
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744223051
Homepage URL
tk10930715@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Nara Medical University
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
Tel
0744223051
tk19830715@gmai.com
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 | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | 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 | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050360
