UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044418
Receipt number R000050740
Scientific Title A prospective study of the optimal depth of anesthesia for remimazolam anesthesia
Date of disclosure of the study information 2021/06/03
Last modified on 2021/06/03 19:26:55

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Basic information

Public title

A prospective study of the optimal depth of anesthesia for remimazolam anesthesia

Acronym

A prospective study on the depth of anesthesia for remimazolam anesthesia

Scientific Title

A prospective study of the optimal depth of anesthesia for remimazolam anesthesia

Scientific Title:Acronym

A prospective study on the depth of anesthesia for remimazolam anesthesia

Region

Japan


Condition

Condition

Not specified

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to analyze the EEG changes induced by the general anesthetic remimazolam and to verify whether a general-purpose anesthesia depth monitor based on EEG changes can be used appropriately.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

EEG changes during remimazolam anesthesia

Key secondary outcomes

The validity of a commercially available depth of anesthesia monitor


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Eligibility criteria are patients who meet the following conditions.
(1) Patients scheduled for general anesthesia surgery with spinal subarachnoid anesthesia at Tohoku University Hospital
(2) Adult patients aged 20 years or older
(3) Gender is not required.

Key exclusion criteria

(1) Pregnant and lactating women
(2) Patients with Child-Pugh classification C or higher
(3) Patients with central nervous system diseases and psychiatric diseases
(4) Patients who regularly use CNS-acting drugs
(5) Heavy drinkers of alcohol and illegal drugs
(6) Patients who cannot communicate in Japanese
(7) Patients who had an adverse reaction to remimazolam and required a change in anesthetic
(8) Patients who could not be awakened from anesthesia and extubated in the operating room immediately after the completion of surgery

Target sample size

50


Research contact person

Name of lead principal investigator

1st name KOTOE
Middle name
Last name KAMATA

Organization

Tohoku University School of Medicine

Division name

Department of Anesthesiology and Perioperative Medicine

Zip code

980-8575

Address

2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi

TEL

+81-22-717-7321

Email

kotoe.kamata.c3@tohoku.ac.jp


Public contact

Name of contact person

1st name KOTOE
Middle name
Last name KAMATA

Organization

Tohoku University School of Medicine

Division name

Department of Anesthesiology and Perioperative Medicine

Zip code

980-8575

Address

2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi

TEL

+81-22-717-7321

Homepage URL


Email

kotoe.kamata.c3@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Center for Gender Equality Promotion

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

Ethics Committee Tohoku University Graduate School of Medicine

Address

2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

2021 Year 06 Month 03 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 04 Month 08 Day

Date of IRB

2021 Year 04 Month 15 Day

Anticipated trial start date

2021 Year 07 Month 01 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

Registration in the UMIN Clinical Trial Registration System
Recruitment of adult patients scheduled for general anesthesia surgery with spinal subarachnoid anesthesia at Tohoku University Hospital (50 patients in total)
1) What we will do in the clinic
Perform spinal subarachnoid anesthesia and confirm that the anesthesia level necessary for surgery is obtained. 2) Perform general anesthesia before induction of general anesthesia. Before induction of general anesthesia, install a general-purpose depth-of-anesthesia monitor and begin EEG recording and depth-of-anesthesia monitoring. Induce general anesthesia with remimazolam and secure the airway. The biometric monitor and EEG data will be automatically transferred to the server in the operating room and stored. Remimazolam administration is discontinued at the end of surgery, and the patient is awakened. If the patient is not awake within 15 minutes after the administration of remimazolam, flumazenil will be administered.
(2) What will be done in this study (additional items to medical practice)
Before induction of general anesthesia, a digital EEG monitor will be additionally installed and recording will begin. The biometric monitor and EEG data obtained during general anesthesia will be stored on a personal computer. Analyze the EEG data (for research purposes). The EEG data recorded by the general anesthesia depth monitor and stored on the personal computer will be analyzed offline (frequency analysis will be performed by Bispectral Analyzer for BIS).
Validation of the general anesthesia depth monitor (for research purposes). Calculate the value of the general anesthesia depth monitor when the power of alpha and beta waves is maximum for each patient.


Management information

Registered date

2021 Year 06 Month 03 Day

Last modified on

2021 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050740


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name