UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050700
Receipt number R000057758
Scientific Title Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia.
Date of disclosure of the study information 2023/04/01
Last modified on 2023/03/28 14:43:14

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Basic information

Public title

Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia.

Acronym

Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia.

Scientific Title

Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia.

Scientific Title:Acronym

Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia.

Region

Japan


Condition

Condition

Elective surgery patient over 18 years old

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The validation for new index(MECK) using sympathetic response can be a indicator of the rate of change of systolic blood pressure (ROCBP) before and after skin incision during remimazolam anesthesia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation coefficient between MECK and ROCBP

Key secondary outcomes

goodness of fit of the prediction equation for ROCBP by MECK under propofol administration in the previous study to the data of this study


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients who under go open surgery which require invasive blood pressure measurement during remimazolam anesthesia.
Patients who are informed enough and presents the will of participation to this study by written form.

Key exclusion criteria

Patients with irregular R-R intervals on the electrocardiogram.
Patients who cannot measure invasive blood pressure in the radial artery.
Patients with severe blood circulation or neuropathy in the upper limbs.
Patients with severe stenosis or obstructive lesions of coronary arteries and cerebrovascular disease.
Patients with contraindicated use of remifentanil or rocuronium.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Saeki
Middle name
Last name Noboru

Organization

Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University

Division name

Department of Anesthesiology and Critical Care

Zip code

734-8551

Address

1-2-3,Kasumi,Minami-ku,Hiroshima

TEL

81-082-327-5267

Email

nsaeki@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Ayaka
Middle name
Last name Ishibashi

Organization

Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University

Division name

Department of Anesthesiology and Critical Care

Zip code

734-8551

Address

1-2-3,Kasumi,Minami-ku,Hiroshima

TEL

81-082-256-5267

Homepage URL


Email

ayakaishibashi1217@gmail.com


Sponsor or person

Institute

Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University

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

Ethical Committee of Hiroshima University

Address

1-2-3,Kasumi,Minami-ku,Hiroshima

Tel

81-082-257-5907

Email

iryo-seisaku@office.hiroshima-u.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

2023 Year 04 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

Enrolling by invitation

Date of protocol fixation

2023 Year 02 Month 03 Day

Date of IRB

2023 Year 02 Month 03 Day

Anticipated trial start date

2023 Year 04 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Measure MECK and the rate of change of systolic blood pressure before and after skin incision under remimazolam and remifentanil 2ng/ml anesthesia.


Management information

Registered date

2023 Year 03 Month 28 Day

Last modified on

2023 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057758


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name