UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041782
Receipt number R000047689
Scientific Title The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study
Date of disclosure of the study information 2020/09/14
Last modified on 2021/09/30 03:20:07

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Basic information

Public title

The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study

Acronym

The relationship between a depth of anesthesia and administration of Remimazolam

Scientific Title

The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study

Scientific Title:Acronym

The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to verify the relationship between a depth of anesthesia and administration of Remimazolam

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The time of loss of consciousness

Key secondary outcomes

EEG changes by an administration of Remimazolam


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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

ASA1-2
elective surgery

Key exclusion criteria

weight<70%, >130%
disease or injury affecting the central nervous system
recent use of psychoactive or analgesic medication

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Kanaya

Organization

Sendai Medical Center

Division name

The department of Anesthesiology

Zip code

983-8520

Address

2-11-12, Myagino, Miyagino-ku, Sendai, Japan

TEL

022-293-1111

Email

canal_village0207@yahoo.co.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Kanaya

Organization

Sendai Medical Center

Division name

The department of Anesthesiology

Zip code

983-8520

Address

2-11-12, Myagino, Miyagino-ku, Sendai, Japan

TEL

022-293-1111

Homepage URL


Email

canal_village0207@yahoo.co.jp


Sponsor or person

Institute

Sendai Medical center

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethical Review Board of Sendai Medical Center

Address

2-11-12, Myagino, Miyagino-ku, Sendai, Japan

Tel

022-293-1111

Email

113-kanri02@mail.hosp.go.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

2020 Year 09 Month 14 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

2020 Year 09 Month 10 Day

Date of IRB

2020 Year 09 Month 10 Day

Anticipated trial start date

2020 Year 09 Month 14 Day

Last follow-up date

2022 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2020 Year 09 Month 14 Day

Last modified on

2021 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047689


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name