UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045195
Receipt number R000051635
Scientific Title Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement
Date of disclosure of the study information 2021/08/20
Last modified on 2023/03/21 23:59:13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement

Acronym

Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement

Scientific Title

Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement

Scientific Title:Acronym

Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement

Region

Japan


Condition

Condition

Aortic valve stenosis

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the usefulness of Remimazolam in anesthesia for transcatheter aortic valve implantation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Time required for awakening

Key secondary outcomes

Hemodynamics during anesthesia
Procedure success rate of TAVI
Postoperative cognitive function


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent transcatheter aortic valve implantation at Kindai University Hospital during the study period.

Key exclusion criteria

Patients who cannot obtain their consent

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name Nakao

Organization

Kindai University Faculty of Medicine

Division name

Department of Anesthesiology and Critical Care

Zip code

5898511

Address

377-2 Ono-Higashi, Osaka-Sayama-city, Osaka, Japan

TEL

0723660221

Email

anesth@med.kindai.ac.jp


Public contact

Name of contact person

1st name Atsuhiro
Middle name
Last name Kitaura

Organization

Kindai University Faculty of Medicine

Division name

Department of Anesthesiology and Critical Care

Zip code

5898511

Address

377-2 Ono-Higashi, Osaka-Sayama-city, Osaka, Japan

TEL

0723660221

Homepage URL

https://www.med.kindai.ac.jp/anes/clinical_study.html

Email

anesth@med.kindai.ac.jp


Sponsor or person

Institute

Kindai University

Institute

Department

Personal name



Funding Source

Organization

Kindai University

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

Kindai University

Address

377-2 Ono-Higashi, Osaka-Sayama-city, Osaka, Japan

Tel

0723660221

Email

anesth@med.kindai.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

近畿大学病院


Other administrative information

Date of disclosure of the study information

2021 Year 08 Month 20 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 07 Month 25 Day

Date of IRB

2021 Year 07 Month 25 Day

Anticipated trial start date

2021 Year 09 Month 01 Day

Last follow-up date

2022 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective observation study. Consent acquisition will be an opt-out method. The evaluation items are extracted from the surgical support system (GAIA) and electronic medical records.


Management information

Registered date

2021 Year 08 Month 19 Day

Last modified on

2023 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051635


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name