UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042650
Receipt number R000048669
Scientific Title Changes in cerebral blood volume and flow during the induction of anesthesia by remimazolam
Date of disclosure of the study information 2020/12/21
Last modified on 2023/04/10 15:17:29

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Basic information

Public title

Changes in cerebral blood volume and flow during the induction of anesthesia by remimazolam

Acronym

Changes in cerebral blood volume and flow by remimazolam

Scientific Title

Changes in cerebral blood volume and flow during the induction of anesthesia by remimazolam

Scientific Title:Acronym

Changes in cerebral blood volume and flow by remimazolam

Region

Japan


Condition

Condition

Patients scheduled to have general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the changes in cerebral blood volume and flow and cerebral oxygenation by using near infrared spectroscopy, tNIRS-1 and transcranial Doppler.

Basic objectives2

Others

Basic objectives -Others

search of the physiological changes

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

changes in cerebral blood volume by remimazolam

Key secondary outcomes

changes in cerebral blood flow and oxygenation by 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

19 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with ASA1,2, who have general anesthesia in Hokkaido University Hospital

Key exclusion criteria

1 patients with intracranial disease
2 patients with circulatory disease

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Morimoto

Organization

Hokkaido University Hospital

Division name

Anesthesiology

Zip code

0608648

Address

N14 W5, Kita-ku, Sapporo

TEL

011-716-1161

Email

morim2@med.hokuda.ac.jp


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Morimoto

Organization

Hokkaido University Hospital

Division name

Anesthesiology

Zip code

0608648

Address

N14 W5, Kita-ku, Sapporo

TEL

011-716-1161

Homepage URL


Email

morim2@med.hokuda.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University Hospital Division of Clinical Research Administration

Address

N14 W5, Kita-ku, Sapporo

Tel

011-706-7636

Email

crjimu@huhp.hokudai.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

2020 Year 12 Month 21 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

15

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 12 Month 03 Day

Date of IRB

2020 Year 12 Month 03 Day

Anticipated trial start date

2021 Year 01 Month 04 Day

Last follow-up date

2022 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study

Study period: until 2022.1.31

Patients who have general anesthesia in Hokkaido University Hospital

Observational items: Background, laboratory data, vital signs, cerebral hemoglobin concentration, cerebral blood flow velocity


Management information

Registered date

2020 Year 12 Month 04 Day

Last modified on

2023 Year 04 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048669


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name