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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045628
Receipt No. 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 2021/10/01

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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
Email 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
Email tk10930715@gmail.com

Sponsor
Institute Nara Medical University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 04 Day
Date of IRB
Anticipated trial start date
2021 Year 09 Month 09 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

Management information
Registered date
2021 Year 10 Month 01 Day
Last modified on
2021 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050360

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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